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 07/23/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history review for the product auto endo5 ml lot #73h1800498 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 stuck during usage on the patient in liver surgery which caused the clip not to be uploaded into the applier.

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 was returned with the rotation tab bent.Functional inspection was performed on the returned sample by attempting to engage the trigger using hand pressure.Upon engagement of the trigger, no audible ratchet sound could be heard indicating that the internal ratchet ears are broken.The first clip was able to load properly into the jaws and was successfully applied to over-stressed surgical tubing.This was repeated with the same result for the last remaining clip.The bent rotation tab is an indication that the clips were out of position and stacking on one another in the channel.The broken ratchet caused the clips to come out of position and could prevent the clips from loading properly into the jaws.The sample was received with 2 clips remaining in the channel, indicating that 13 clips were fired by the end user.It could not be determined what exactly caused the ratchet ears 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 broken ratchet could prevent the clips from loading properly into the jaws.It could not be determined what exactly caused the ratchet ears to break but a nonconformance has been opened to further investigate this issue.The reported complaint of "clip stuck in applier" was not confirmed based upon the sample received.Upon functional inspection, the remaining clips fired properly.However, a defect was found as 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 rotation tab was also bent.The bent rotation tab is an indication that the clips were out of position and stacking on one another in the channel.The broken ratchet caused the clips to come out of position and could prevent the clips from loading properly into the jaws.It could not be determined what exactly caused the ratchet ears to break but nc b)(4) has been opened to further investigate this issue.

Event Description

It was reported that the clip was stuck during usage on the patient in liver surgery which caused the clip not to be uploaded into the applier.

Manufacturer Narrative

(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.

• Brand Name: AUTO ENDO5 ML
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8907938
• MDR Text Key: 154789296
• Report Number: 3003898360-2019-01000
• 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: 07/25/2019

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: 73H1800498
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2019
• Initial Date Manufacturer Received: 07/25/2019
• Initial Date FDA Received: 08/19/2019
• Supplement Dates Manufacturer Received: 09/11/2019; 09/11/2019
• Supplement Dates FDA Received: 09/19/2019; 11/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention