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

Catalog Number AE05ML

Device Problems Difficult to Open or Close (2921); Device Fell (4014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/29/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the applier was loading clips that were closed and one clip shot out the side of the applier.

Manufacturer Narrative

(b)(4).Per dhr the product auto endo5 ml lot # 73f1900178 was manufactured on 06/05/2019 a total of (b)(4) pieces.Lot was released on 06/11/2019.Dhr investigation did not show issues related to complaint.The customer returned one unit ae05ml autoend05 ml for investigation.The returned sample was visually examined with and without mag nification.Visual examination of the returned device revealed that the sample was returned with its trigger partially engaged and with no clip in first position of the channel.The sample appears used as there is biological material present on the device.Reference file anp1900073131 for investigation photos.First, the trigger cycle was completed.Functional inspection was then 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 on the first attempt.This was repeated several times with the same result.The sample was disassembled to inspect the internal component.No further 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 anp1900073131 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 "clip not loading properly" 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 applier was loading clips that were closed and one clip shot out the side of the applier.

• Brand Name: AUTO ENDO5 ML
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 9340731
• MDR Text Key: 170731107
• Report Number: 3003898360-2019-01366
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AE05ML
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2019
• Date Manufacturer Received: 12/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1