MAUDE Adverse Event Report: TELEFLEX MEDICAL HEM-O-LOK AUTO ENDO5 ML LIGATING CLIP APPLIER; CLIP, IMPLANTABLE

Model Number IPN010797

Device Problems Activation, Positioning or Separation Problem (2906); Difficult to Open or Close (2921); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/17/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history review for the product auto endo5 ml lot# 73d1900013 investigation did not show issues related to complaint.The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that the clips do not come out well from the applier, does not close, crossed over each other or jammed.

Event Description

It was reported that the clips do not come out well from the applier, does not close, crossed over each other or jammed.

Manufacturer Narrative

Qn# (b)(4).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.Adhesive residue was observed on the handle.Reference file (b)(4) for investigation photos.First, the trigger cycle was completed.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 able to properly load into the jaws of the applier and was successfully applied to over-stressed surgical tubing.This was repeated with the same result for the remaining clips.The sample was received with 7 clips remaining in the channel indicating that 8 clips were fired by the end user.No defects or anomalies were observed.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." the reported complaint of "clip crossed over each other" was not confirmed based upon the sample received.One device was returned.Upon functional inspection, no problems were found as all remaining clips were able to properly load into the jaws and were successfully applied to over-stressed surgical tubing.The device was received with 7 clips remaining in the channel indicating that the end user fired 8 clips.A device history record review was performed on the device with no evidence to suggest a manufacturing related cause.No functional issues were found with the returned device.

• Brand Name: HEM-O-LOK AUTO ENDO5 ML LIGATING CLIP APPLIER
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 9569630
• MDR Text Key: 175835800
• Report Number: 3003898360-2020-00079
• 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,u
• Type of Report: Initial,Followup
• Report Date: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: IPN010797
• Device Catalogue Number: AE05ML
• Device Lot Number: 73D1900013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Date Manufacturer Received: 02/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1