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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL AUTO ENDO5 ML; CLIP, IMPLANTABLE
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TELEFLEX MEDICAL AUTO ENDO5 ML; CLIP, IMPLANTABLE Back to Search Results
Catalog Number AE05ML
Device Problems Premature Activation (1484); Activation, Positioning or Separation Problem (2906)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/08/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device history review for the product auto endo5 ml lot# 73g1800873 investigation did not show issues related to the complaint.Teleflex will continue to monitor and trend related events.
 
Event Description
It was reported that during laparoscopic cholecystectomy, a clip was not loaded into the jaws properly.At the second trial of loading, the clip got broken and fell in the patient's abdominal cavity.The fallen clip was retrieved and the user replaced the device with a new one to continue the surgery.
 
Event Description
It was reported that during laparoscopic cholecystectomy, a clip was not loaded into the jaws properly.At the second trial of loading, the clip got broken and fell in the patient's abdominal cavity.The fallen clip was retrieved and the user replaced the device with a new one to continue the surgery.
 
Manufacturer Narrative
(b)(4).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 was returned with its trigger partially engaged and a protective plastic tube over the jaws of the device.It was also observed that the rotation tab was bent , and a clip was partially loaded incorrectly into the jaws of the device.The returned sample appears used as there is biological material present on the device.This sample was reviewed with a r & d engineer.First, the partially loaded clip was manually removed , and 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 could be heard indicating that the internal ratchet ears are intact.The first clip was able to load properly into the jaws of the device and was successfully applied to over-stressed surgical tubing.Another attempt was made and this time, the clip was unable to load properly.It was observed that the feeder was to the side of the clip.The sample was disassembled to inspect the internal components.It was found that the clips were out of position and stacking on one another.The clip stacking could prevent the clips from properly loading into the jaws.The sample was received with 10 clips remaining, including the partially loaded clip indicating that 5 clips were fired by the end user.A non-conformance has been opened to further investigate this issue.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." although the root cause of this complaint issue could not be determined, a non-conformance has been opened to further investigate the clip stacking issue.The reported complaint of "clip fell from applier" was confirmed based upon the sample received.One device was returned with 10 clips remaining, including the partially loaded clip indicating that 5 clips were fired by the end user.Upon functional inspection, it was found that the clips were out of position and stacking on one another which prevented the clips from loading properly into the jaws of the device.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 non-conformance has been opened to further investigate this issue.
 
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Brand Name
AUTO ENDO5 ML
Type of Device
CLIP, IMPLANTABLE
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
MDR Report Key8378077
MDR Text Key137407387
Report Number3003898360-2019-00239
Device Sequence Number1
Product Code FZP
Combination Product (y/n)N
PMA/PMN Number
K152081
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 02/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/29/2021
Device Catalogue NumberAE05ML
Device Lot Number73G1800873
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/15/2019
Date Manufacturer Received03/29/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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