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

Catalog Number AE05ML

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/10/2020

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 after several ligations, a clip got stuck in the applier and did not come out to be loaded.Therefore, the device was replaced the with a new one.No clip fell/remained in patient.

Manufacturer Narrative

(b)(4).Per dhr the product auto endo5 ml lot # 73c1900605 was manufactured on 03/25/2019 a total of (b)(4) pieces.Lot was released on 04/17/2019.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 magnification.Visual examination of the returned device revealed that the sample appears used as there is biological material present on the device.Reference attached file (b)(4) for investigation photos.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 was heard indicating that the internal ratchet ears are intact.The first clip was unable to properly load as it did not latch onto the top jaw.It was noticed that there was a small buildup of biological material in the top jaw.The buildup was manually removed and another attempt to fire a clip was made.The next clip was also unable to load properly.The third clip was able to load properly and was successfully attached to over-stressed surgical tubing.However, the fourth clip also failed to properly load.The device was disassembled in order to inspect the internal components.Upon disassembly, it was found that the top jaw had a bent jaw leg.No other damages were observed.The sample was received with 6 clips remaining in the channel indicating that 9 clips were fired by the end user.The damage to the jaw leg prevented the clips from loading properly since the jaws were misaligned.It appears that a significant side load was applied to the top jaw which caused the observed damages.Reference file anp1900075429 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 the condition of the sample received indicates that unintentional user error caused or contributed to this event.The reported complaint of "clip stuck in applier" was confirmed based upon the sample received.Upon functional inspection, it was found that the top jaw had a bent jaw leg which prevented the clips from consistently firing properly.At the time of manufacturing assembly, the autoend05 is 100% inspected for proper clip loading and closure.It is unlikely that this type of damage was present at the time of manufacturing.A device history record review was performed on the device with no evidence to suggest a manufacturing related defect.Based upon the observed damage, unintentional user error caused or contributed to this event.

Event Description

It was reported that after several ligations, a clip got stuck in the applier and did not come out to be loaded.Therefore, the device was replaced the with a new one.No clip fell/remained in patient.

• Brand Name: AUTO ENDO5 ML
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 9716706
• MDR Text Key: 180133497
• Report Number: 3003898360-2020-00209
• 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: 02/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/04/2022
• Device Catalogue Number: AE05ML
• Device Lot Number: 73C1900605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2020
• Date Manufacturer Received: 03/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1