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 04/01/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that after several ligations the user could not ligate a clip during a lapascorpic uterus malignant tumor resection.Therefore, the device was replaced with a new one to complete the operation.No further information provided so far.

Event Description

It was reported that after several ligations the user could not ligate a clip during a lapascorpic uterus malignant tumor resection.Therefore, the device was replaced with a new one to complete the operation.No further information provided so far.

Manufacturer Narrative

(b)(4).Per dhr the product auto endo5 ml lot # 73f1900180 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 tube was severely bent and the trigger was partially engaged.The damage to the outer tube would prevent the device from firing properly.The returned sample appears used as there is biological material present on the device.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 "unable to ligate" was confirmed based upon the sample received.The sample was returned with the tube severely bent.Functional testing could not be performed since the damage to the outer tube would prevent the device from firing.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.

• Brand Name: AUTO ENDO5 ML
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 9977865
• MDR Text Key: 188385387
• Report Number: 3003898360-2020-00377
• 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: 04/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/04/2022
• Device Catalogue Number: AE05ML
• Device Lot Number: 73F1900180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2020
• Initial Date Manufacturer Received: 04/01/2020
• Initial Date FDA Received: 04/20/2020
• Supplement Dates Manufacturer Received: 05/19/2020
• Supplement Dates FDA Received: 05/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1