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

Catalog Number AE05ML

Device Problems Leak/Splash (1354); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/24/2019

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).The customer returned one-unit ae05ml autoend05 ml for investigation.The returned sample was visually examined with and without magnification.Visual examination of the returned device revealed that the sample was returned with its rotation tab bent and the first clip protruding from the channel.It was observed that the second clip was right behind the first clip.The returned sample appears used as there is biological material present on the device.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 could be heard indicating that the internal ratchet ears are intact.The first clip was unable to load properly.It was observed that the clip became stuck in the bent rotation tab and a double feed occurred.The first two clips were manually removed, and the sample was disassembled to inspect the internal components.Upon disassembly, it was found that the clips were out of position and stacking on one another.The clip stacking could prevent the clips from properly loading into the jaws of the device.The sample was received with 10 clips remaining in the channel indicating that 5 clips were fired by the end user.Non-conformance has been opened to further investigate this issue.The device history review for the product auto endo5 ml lot# 73g1800265 investigation did not show issues related to the complaint.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." although the root cause of this complaint issue could not be determined, non-conformance has been opened to further investigate the clip stacking issue.The reported complaint of clips not loading properly was confirmed based upon the sample received.Although the reported complaint issue was confirmed based on functional testing, it could not be determined exactly how or when the clips became out of position.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that during laparoscopic cholecystectomy, around the fourth clip was loaded into the jaws slanted.An attempt to re-load after removing the clip also failed, so that the user replaced the applier with a new one.The new applier clips were often stuck from around the fourth one.No clips fell in the patient and no health injury occurred in both cases.

• Brand Name: AUTO ENDO5 ML
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 8478800
• MDR Text Key: 140804257
• Report Number: 3003898360-2019-00383
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K152081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/20/2019

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: 07/09/2021
• Device Catalogue Number: AE05ML
• Device Lot Number: 73G1800265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2019
• Initial Date FDA Received: 04/03/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/10/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1