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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.
 
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 typical.Functional inspection was performed on the returned sample by attempting to engage the trigger using hand pressure.Upon engagement of the trigger, no audible ratchet sound could be heard indicating that the internal ratchet ears are broken.The first clip was able to properly load into the jaws and was successfully applied to over-stressed surgical tubing.Another attempt was made , and the second clip was unable to properly load as the clip was to the side of the pusher head (distal end of feeder).The sample was disassembled to inspect the internal components.It was found that the clips were out of position and stacking on one another in the channel.The broken ratchet caused the clips to become out of position and prevented the clips from properly loading into the jaws.The sample was received with 12 clips remaining in the channel indicating that 3 clips were fired by the end user.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 broken ratchet prevented the clips from loading properly 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 reported complaint of "clip stuck in applier" was confirmed based upon the sample received.One device was returned.Upon functional inspection, the 2nd clip was unable to properly load as the clip was to the side of the pusher head (distal end of feeder).The device was found to have broken internal ratchet ears which could affect the end user's ability to properly load and apply clips.The sample was disassembled , and it was found that the clips were out of position and stacking on one another in the channel.The broken ratchet caused the clips to become out of position and prevented the 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.
 
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 Key8942264
MDR Text Key155938180
Report Number3003898360-2019-01033
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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