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

Catalog Number AE05ML

Device Problems Failure to Advance (2524); Device Fell (4014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/08/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history review for the product auto endo5 ml lot #73l1800543 investigation did not show issues related to the complaint.The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that during laparoscopic cholecystectomy, the first clip got stuck and did not come to the jaws.After firing the applier several times outside the patient body, the md tried to load a clip in the patient again, however, the fourth clip fell at loading.The fallen clip was retrieved; no clip remained in the patient, and no injury to the patient occurred.

Manufacturer Narrative

Qn# (b)(4).After an additional medical review, a determination was made to re-classify the complaint as a malfunction.Complaint (b)(4) is being reported as a malfunction.There was no serious injury.

Manufacturer Narrative

Qn#(b)(4).The customer returned one unit ae05ml autoend05 ml for investigation.The sample is for tc (b)(6) and tc (b)(6).The returned sample was visually examined with and without magnification.Visual examination of the returned device revealed that the sample was returned with its trigger partially engaged and the rotation tab bent.A clip with a broken hook was partially loaded incorrectly.The 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." the reported complaint of "clip fell from applier" was confirmed based upon the sample received.One device was returned with the rotation tab bent.A clip with a broken hook was partially loaded incorrectly.Upon functional inspection, the first clip was unable to load properly into the jaws.The next clip had a broken hook and was protruding from the channel.The sample was disassembled , and it was found that the clips were out of position and stacking on one another.The proximal end of the feeder was slightly bent due to the clip stacking.Two of the returned clips were broken at the hook.The clip stacking prevented the clips from loading properly into the jaws.The clip stacking can also cause the clips to break in the channel, as observed with this sample.Although the reported complaint issue was confirmed based on functional testing, it could not be determined exactly how or when the clips became out of position.A capa has been opened to further investigate this issue.

Event Description

It was reported that during laparoscopic cholecystectomy, the first clip got stuck and did not come to the jaws.After firing the applier several times outside the patient body, the md tried to load a clip in the patient again, however, the fourth clip fell at loading.The fallen clip was retrieved; no clip remained in the patient, and no injury to the patient occurred.

• Brand Name: AUTO ENDO5 ML
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8936409
• MDR Text Key: 155712595
• Report Number: 3003898360-2019-01028
• 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,Followup
• Report Date: 08/08/2019

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: 11/18/2021
• Device Catalogue Number: AE05ML
• Device Lot Number: 73L1800543
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2019
• Initial Date Manufacturer Received: 08/08/2019
• Initial Date FDA Received: 08/27/2019
• Supplement Dates Manufacturer Received: 09/20/2019; 09/20/2019
• Supplement Dates FDA Received: 10/02/2019; 11/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention