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

Catalog Number 543965

Device Problems Failure to Advance (2524); Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/09/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history review for the product auto endo5 ml lot #73h1800502 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 (b)(6) 2019, the professor in biliary pancreatic surgery of reported that about the fifth clip was stuck and loose during usage on the patient which caused the clip not to be closed properly.

Manufacturer Narrative

Qn# (b)(4).After an additional medical review, a determination was made to re-classify the complaint as a malfunction.Complaint number (b)(4) is being reported as a malfunction.There was no serious injury.

Event Description

It was reported that (b)(6) 2019, the professor in biliary pancreatic surgery of reported that about the fifth clip was stuck and loose during usage on the patient which caused the clip not to be closed properly.

Manufacturer Narrative

Qn# (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 13 clips remaining in the channel indicating that 2 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 "clip stuck in applier" 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 applied 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 13 clips remaining in the channel indicating that 2 clips were fired by the end user.Although the reported complaint issue could not be confirmed, 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 nononformance has been opened to further investigate this issue.

• Brand Name: AUTO ENDO5 ML
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8932170
• MDR Text Key: 155576996
• Report Number: 3003898360-2019-01049
• 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: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 08/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/15/2021
• Device Catalogue Number: 543965
• Device Lot Number: 73H1800502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2019
• Initial Date Manufacturer Received: 08/10/2019
• Initial Date FDA Received: 08/26/2019
• Supplement Dates Manufacturer Received: 09/23/2019; 09/23/2019
• Supplement Dates FDA Received: 10/02/2019; 11/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention