MAUDE Adverse Event Report: TELEFLEX MEDICAL AUTO ENDO5 ML; CLIP, IMPLANTABLE

Catalog Number AE05ML

Device Problem Device Fell (4014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history review for the product auto endo5 ml lot# 73e1900346 investigation did not show issues related to the complaint.The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that after several ligations during an operation a clip fell at loading.Therefore, another device of the same lot was used however, the same issue occurred.Then the operation was completed with no problem by using the other device.All the fallen clips were retrieved so that no clip remained in the patient and there was no injury to the patient reported.

Manufacturer Narrative

Qn#(b)(4).The customer returned one unopened representative sample ae05ml autoend05 ml for investigation.The returned sample was visually exa mined with and without magnification.Visual examination of the returned device revealed that the sample appears typical.Reference file anp1900073930 for investigation photos.Functional inspection was performed on the returned representative sample.Using hand pressure, the trigger was engaged.Upon engagement of the trigger, an audible ratchet sound could be heard indicating that the internal ratchet ears are intact.The first clip was able to properly load into the jaws of the applier and was successfully applied to over-stressed surgical tubing.This was repeated with the same result for the remaining clips.No functional issues were found with the returned representative sample.Reference file anp1900073930 for investigation photos.The ifu for this product, l06072, was reviewed as a part of this complaint investigation.The ifu for this product states, "mishandling of appliers may result in improper load and/or closure of the ligating clip." a corrective action is not required at this time as there was only a representative sample returned and no functional issues were found with the returned representative sample.The reported complaint of "clip fell from applier" could not be confirmed since the actual sample was not returned.One representative sample was returned.Upon functional inspection, no functional issues were found as all clips fired properly.The probable cause of this issue could not be determined without the actual sample.

Event Description

It was reported that after several ligations during an operation a clip fell at loading.Therefore, another device of the same lot was used however, the same issue occurred.Then the operation was completed with no problem by using the other device.All the fallen clips were retrieved so that no clip remained in the patient and there was no injury to the patient reported.

Event Description

It was reported that after several ligations during an operation a clip fell at loading.Therefore, another device of the same lot was used however, the same issue occurred.Then the operation was completed with no problem by using the other device.All the fallen clips were retrieved so that no clip remained in the patient and there was no injury to the patient reported.

Manufacturer Narrative

Qn#(b)(4).The customer returned two units ae05ml autoend05 ml for investigation.The actual sample and a representative sample were returned.The returned samples were visually examined with and without magnification.Visual examination of the actual sample revealed that the sample was returned with its trigger partially engaged and a clip loaded properly into the jaws.The sample appears used as there is biological material present on the device.The representative sample appears typical.Reference file anp1900073930 for investigation photos.First, the clip was manually removed , and the trigger cycle was completed.Functional inspection was performed on the returned sample by attempting to engage the trigger using hand pressure.Upon engagement of the trigger, an audible ratchet sound was heard indicating that the internal ratchet ears are intact.The first clip was unable to properly load into the jaws as it was unable to latch onto the bottom jaw.Another attempt was made with the same result.Upon further examination, it was noticed that there was a buildup of biological material in the bottom jaw.The buildup was manually removed , and another attempt was made to fire the device.This time, a clip was able to properly load into the jaws of the applier and was successfully applied to over-stressed tubing.This was repeated with the same result for the remaining clips.The device was returned with 8 clips remaining in the channel, indicating that 7 clips were fired by the end user.Next, the representative sample was tested.Upon engagement of the trigger, an audible ratchet sound could be heard indicating that the internal ratchet ears are intact.The first clip was able to load properly into the jaws of the device and was successfully applied to over-stressed surgical tubing.This was repeated with the same result for the remaining clips.There were no functional issues found with the returned representative sample.The root cause of this complaint issue is the buildup of biological material in the bottom jaw.There were no functional issues found with the device itself.Therefore, based on the condition of the returned sample, unintentional user error caused or contributed to this event.Reference file anp1900073930 for investigation photos.The ifu for this product, l06072, was reviewed as a part of this complaint investigation.The ifu for this product states, "mishandling of appliers may result in improper load and/or closure of the ligating clip." a corrective action is not required at this time as the condition of the sample received indicates that unintentional user error caused or contributed to this event.The reported complaint of "clip fell from applier" was confirmed based upon the sample received.One device was returned with 8 clips remaining in the channel, indicating that 7 clips were fired by the end user.Upon functional inspection of the actual sample, it was found that a buildup of biological material was stuck in the bottom jaw which prevented the first clip tested from properly loading.Once the buildup was removed, the remaining clips were able to fire properly.There were no functional issues found with the device.Since the first clip was unable to load due to the buildup of biological material in the bottom jaw, unintentional user error caused or contributed to this event.

• Brand Name: AUTO ENDO5 ML
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 9481507
• MDR Text Key: 173227031
• Report Number: 3003898360-2019-01494
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• PMA/PMN Number: K152081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/12/2022
• Device Catalogue Number: AE05ML
• Device Lot Number: 73E1900346
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Initial Date Manufacturer Received: 12/03/2019
• Initial Date FDA Received: 12/17/2019
• Supplement Dates Manufacturer Received: 02/01/2020; 02/11/2020
• Supplement Dates FDA Received: 02/04/2020; 02/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1