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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 543965
Device Problems Failure to Advance (2524); Difficult to Open or Close (2921)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/05/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device history review for the product auto endo5 ml, lot #73h1800502.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 gastrointestinal surgery the eighth clip was stuck and loose during usage on the patient which caused the clip not to be closed properly.Then change to another applier while the same issue happened again when the fifth clip was used.
 
Manufacturer Narrative
Qn# (b)(4).The customer returned one unit 543965 autoendo5 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.No clip is in the first position in the channel.A buildup of biological material was present on the bottom jaw.Functional inspection was performed on the returned sample by attempting to engage the trigger using hand pressure.Upon engagement of the trigger, no ratchet sound could be heard indicating that the internal ratchet ears are broken.No clip fired on the first attempt.On the next attempt, the clip was unable to load properly as it did not latch onto the bottom jaw due to the buildup of biological material.The buildup of biological material was manually removed , and another attempt was made.The next clip was able to properly load into the jaws of the device 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 5 clips remaining in the channel indicating that 10 clips were fired by the end user.The broken ratchet and the buildup of biological material in the bottom jaw could prevent clips from properly loading into the jaws.It could not be determined what exactly caused the ratchet ears to break but a nonconformance has been opened to further investigate this issue.The ifu for this product, l03496, 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 stuck in applier" was confirmed based upon the sample received.One device was returned.Upon functional inspection, one of the remaining clips was unable to properly load into the jaws of the device.The device was found to have broken internal ratchet ears and a buildup of biological material in the bottom jaw which could affect the end user's ability to properly load and apply clips.The device was received with 5 clips remaining in the channel indicating that 10 clips were fired by the end user.It could not be determined what exactly caused the ratchet ears to break but a nonconformace has been opened to further investigate this issue.
 
Event Description
It was reported that during gastrointestinal surgery the eighth clip was stuck and loose during usage on the patient which caused the clip not to be closed properly.Then change to another applier while the same issue happened again when the fifth clip was used.
 
Manufacturer Narrative
(b)(4).After an additional medical review, a determination was made to re-classify the complaint as a malfunction.Complaint number (b)(4) is being reported as a malfunction.There was no serious injury.
 
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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 Key8942280
MDR Text Key155930373
Report Number3003898360-2019-01034
Device Sequence Number1
Product Code FZP
Combination Product (y/n)N
PMA/PMN Number
K021808
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup,Followup
Report Date 08/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/28/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/15/2021
Device Catalogue Number543965
Device Lot Number73H1800502
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/28/2019
Date Manufacturer Received09/23/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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