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

Model Number IPN010797

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history review could not be conducted since the lot number was not provided.The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that the clip broke during use in surgery.

Manufacturer Narrative

(b)(4).Per dhr the product auto endo5 ml lot # 73g1900043 was manufactured on 07/01/2019 a total of (b)(4) pieces.Lot was released on 07/09/2019.Dhr investigation did not show issues related to complaint.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.No clip fired.Several more attempts were made, but no clips fired.The sample was disassembled to observe the internal components.Upon disassembly, no damages were observed.The device was returned with 0 clips remaining in the channel indicating that all 15 clips were fired by the end user.Since no clips were returned, the reported complaint issue could not be confirmed.Reference file (b)(4) 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 it could not be determined what caused the complaint issue since no clips were remaining in the returned sample.The device history record review showed no evidence to suggest a manufacturing related cause.The reported complaint of "clips broke during use" was not confirmed based upon the sample received.One device was returned.The device was received with 0 clips remaining in the channel indicating that all 15 clips were fired by the end user.At the time of manufacturing assembly, the autoend05 is 100% inspected for proper clip loading and closure.A device history record review was performed on the autoend05 with no evidence to suggest a manufacturing related cause.Since there were no clips remaining in the returned device, the reported complaint issue could not be confirmed , and a probable cause could not be determined.

Event Description

It was reported that the clip broke during use in surgery.

• Brand Name: AUTO ENDO5 ML
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 9694803
• MDR Text Key: 179414873
• Report Number: 3003898360-2020-00185
• 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
• Report Date: 01/24/2020

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: 06/30/2022
• Device Model Number: IPN010797
• Device Catalogue Number: AE05ML
• Device Lot Number: 73G1900043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2020
• Initial Date Manufacturer Received: 01/24/2020
• Initial Date FDA Received: 02/11/2020
• Supplement Dates Manufacturer Received: 03/18/2020
• Supplement Dates FDA Received: 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1