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

Catalog Number 543965

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history review for the product auto endo5 ml lot #73h1800235 investigation did not show issues related to the complaint.The device investigation is pending.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that the clip was found stuck and loose after 1 clip was fired, so the hol could not be closed properly.

Manufacturer Narrative

(b)(4).The customer returned one unit 543965 autoendo5 ml for investigation.The returned sample was visually examined with and without magnification.Visual examination of the returned device revealed that the 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, no ratchet sound could be heard indicating that the internal ratchet ears are broken.The first clip was able to properly load 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.The sample was received with 11 clips remaining in the channel indicating that 4 clips were fired by the end user.Although the remaining clips were able to fire properly, the broken ratchet could prevent the clips from properly loading into the jaws.It could not be determined what exactly caused the ratchet to break but a nonconformance has been opened to further investigate this issue.The ifu for this product, l03496, 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." the reported complaint of "failure to function" was not confirmed based upon the sample received.One device was returned.Upon functional inspection, all of the remaining clips were able to properly load into the jaws of the device and were successfully attached to over-stressed surgical tubing.However, the device was found to have broken internal ratchet ears which could affect the end user's ability to properly load and apply clips.The device was received with 11 clips remaining in the channel indicating that 4 clips were fired by the end user.Although the reported complaint issue could not be confirmed since all of the clips in the returned device properly loaded, the broken internal ratchet ears could cause issues with loading of the clips.It could not be determined what exactly caused the ratchet ears to break but a nonconformance has been opened to further investigate this issue.

Event Description

It was reported that the clip was found stuck and loose after 1 clip was fired, so the hol could not be closed properly.

• Brand Name: AUTO ENDO5 ML
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8799520
• MDR Text Key: 151340810
• Report Number: 3003898360-2019-00869
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• PMA/PMN Number: K021808
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/02/2019

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: 08/12/2021
• Device Catalogue Number: 543965
• Device Lot Number: 73H1800235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Initial Date Manufacturer Received: 07/02/2019
• Initial Date FDA Received: 07/17/2019
• Supplement Dates Manufacturer Received: 08/20/2019
• Supplement Dates FDA Received: 08/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1