引言
8月22日，Ambu又如期发布了财年Q3报告。数据依旧非常漂亮。
受整个肺病学产品组合的推动，支气管镜第三季度实现了11.2%的稳健增长，过去12个月的滚动有机增长率为10.7%。
基本面增长依然强劲，尽管这是最成熟的一次性内窥镜市场，但一次性支气管镜产品的渗透率仍有进一步扩大的空间。
今天看一起去年8月份AScope4型号支气管镜的不良事件。
02 Ambu 2024FDA不良事件
2024年8月24日，FDA的MAUDE系统上披露了一起支气管镜不良事件。
不良事件报告涉及的产品系列：Ascope4支气管，老款的支气管镜。
详细描述如下：
Event description: customer reported, that while performing an alveolar lavage during bronchial fibroscopy, rubber occlusive membrane of the fiberscope's operating channel ruptured and part of it fell into patient's bronchial tree. They were not able to recover it. Patient was admitted to intensive care unit for respiratory distress and undergone fibrescopy on the same day. Patient continued to be hospitalized in intensive care and actions were taken in the hospital to manage the patient.
事件描述：
客户报告称，在进行支气管纤维镜检查期间的肺泡灌洗操作时，纤维镜操作通道的橡胶封闭膜发生破裂，其中一部分掉入了患者的支气管内。医务人员未能将该破裂部分取出。患者因出现呼吸困难被送入重症监护室，并于当天接受了再次纤维镜检查。患者目前仍在重症监护病房住院，医院方面已采取相应措施对其进行治疗和管理。
Manufacturer narrative: sample is currently with the healthcare facility, however has been requested for investigation. Investigation of the complaint is currently on-going at the manufacturing site. A follow-up MDR report will be submitted when the investigation has been completed.
Follow-up #1 01-10-2025.
D9 - device not available for investigation.
G3 - date updated for when the investigation results became available.
H6 - coding modified for annex b, c and d.
H10 - importer report number added.
H11 : we are unable to verify the reported failure as the actual sample nor pictures were returned for investigation. Since the failure happened during alveolar lavage procedure, we suspect that endotracheal tube (ett) was used in order to isolate lungs and prevent fluid leakage into the ventilated lung. Retention sample from the same lot was retrieved for testing and it was confirmed that lubricated sample could smoothly pass through compatible ett. Simulation test was conducted by pulling out the scope of ett while bending section was not in neutral position and with minimal lubrication and damage to the bending section was observed. It is suspected that the possible cause of reported failure was that there was insufficient lubrication and that the bending section of the working channel was not in neutral position while removing the scope from ett with excessive force. However, the root cause could not be established due to insufficient information. Ambu production and quality performs 100% visual inspection and bending functionality inspection on each of the scope prior shipment. IFU states: 'when withdrawing the endoscope, the distal tip must be in neutral and non-deflected position.' and 'lubricate the insertion cord with a medical grade lubricant when the endoscope is inserted into the patient.' quality alert has been raised to industrial engineering, production and quality control to alert them on this market complaint. We will continue monitoring the market for similar complaints.
Manufacturer narrative: sample is currently with the healthcare facility, however has been requested for investigation. Investigation of the complaint is currently on-going at the manufacturing site. A follow-up MDR report will be submitted when the investigation has been completed.
制造商说明：
目前该器械样本仍留存在医疗机构处，但我们已要求将其取回以供调查。制造商工厂正在对此次投诉进行调查，调查仍在进行中。待调查完成后，我们将提交一份后续医疗器械不良事件报告（MDR Follow-up Report）。
后续报告 #1 日期：2025年10月1日（01-10-2025）相关编码说明：
D9：器械目前无法用于调查（尚未取回）
G3：调查结果可获取的日期已更新
H6：根据附件 B、C 和 D 更新了编码
H10：添加了进口商报告编号
H11：我们无法验证所报告的故障，因为既未退回实际样本，也未提供图片用于调查。由于故障发生在肺泡灌洗操作过程中，我们推测当时可能使用了气管插管（ETT）来隔离肺部，防止灌洗液流入通气肺。我们取回了同一批次的留样进行测试，证实润滑后的样本可顺利通过兼容的气管插管。我们还进行了模拟测试：在弯曲段未处于中立位置、且润滑不足的情况下，将纤维镜从气管插管中拔出，结果观察到弯曲段出现损伤。
据此推测，此次报告的故障可能原因包括：润滑不足，以及在从气管插管中拔出纤维镜时，操作通道的弯曲段未处于中立位置，且用力过猛。但由于信息不足，尚无法确定根本原因。
Ambu 在产品出厂前，对每支内镜均执行 100% 目视检查和弯曲功能测试。使用说明书（IFU）中明确指出：
“在撤出内镜时，远端尖端必须处于中立且无偏转的位置。”
“将内镜插入患者体内时，应使用医用级润滑剂对插入管进行润滑。”
我们已向工程、生产及质量控制部门发出质量警示，提醒其关注此次市场投诉。我们将继续监测市场上是否出现类似投诉。
制造商说明（补充/重复）：
目前该器械样本仍留存在医疗机构处，但我们已要求将其取回以供调查。制造商工厂正在对此次投诉进行调查，调查仍在进行中。待调查完成后，我们将提交一份后续医疗器械不良事件报告（MDR Follow-up Report）。
03 一些思考
这起不良事件至今应该还未关闭，因为耗材类产品很难有问题样品保留下来并返厂进行详细调查。后续大概也就不了了之。
从严重性来看，其实已经对患者造成了伤害。厂家把原因定位为使用者未按照说明书指示使用充分的医用润滑剂。
不知道有没有可能是工作通道内橡胶膜的材料问题。
原来我们选择类似材料，考虑点都是生物相容性，因为过型检的话，这是硬性要求。
从这起不良事件中看，可能还要考虑材料是否易碎，特别是支气管这种应用场景，碎片掉入较细的支气管分支，非常不好取出，对病患的伤害是很明显的。耗材从厂家生产出来到医院使用上，这中间还有很长的贮存链条。而耗材之所以有货架时间，其中有一部分原因就是考虑材料随时间老化的问题。不仅是工作通道里面用到的橡胶膜，一次性内镜用到的很多材料可能都会涉及这个问题。