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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HOL ML 5 MILLIMETER ENDO APPLIER; APPLIER, SURGICAL, CLIP
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TELEFLEX MEDICAL HOL ML 5 MILLIMETER ENDO APPLIER; APPLIER, SURGICAL, CLIP Back to Search Results
Catalog Number 544965
Device Problem Separation Failure (2547)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/19/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
 
Event Description
It was reported that during robot-assisted laparoscopic radical prostatectomy, the user ligated the patient's blood vessel with a clip, but it remained stuck in the jaw of the applier.The user could not ligate the blood vessel.Another applier was used.No clips fell from the applier in the patient.There was no reported patient's injury because of this issue.
 
Manufacturer Narrative
(b)(4).The dhr for the returned instrument was reviewed and found completely without any irregularities.This instrument was manufactured at the (b)(4) as part of a 50 pc.Lot in (b)(6) of 2017.The returned instrument was evaluated and found that the tube assembly is damaged/bent open at the jaw end and the jaws are loose and misaligned and the drive rod is bent/damaged at the jaw end thus we are able to validate this complaint.Parts were 100% visually inspected and tested at the (b)(4) before instruments were sent to customer.No irregularities were found and or reported at the time of inspection and assembly of the product, as this is a standardized process for all instruments manufactured at this facility.At this time it is un-determined what caused the tube assembly to be damaged and for the drive rod to be bent at the jaw engagement area and for the jaws to be loose and misaligned and the jaw pivot pin to be partially pulled into the outer tube assembly but mishandling at end users facility is suspected.
 
Event Description
It was reported that during robot-assisted laparoscopic radical prostatectomy, the user ligated the patient's blood vessel with a clip, but it remained stuck in the jaw of the applier.The user could not ligate the blood vessel.Another applier was used.No clips fell from the applier in the patient.There was no reported patient's injury because of this issue.
 
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Brand Name
HOL ML 5 MILLIMETER ENDO APPLIER
Type of Device
APPLIER, SURGICAL, CLIP
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
MDR Report Key7753221
MDR Text Key116215581
Report Number3011137372-2018-00219
Device Sequence Number1
Product Code GDO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 07/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number544965
Device Lot Number06C1748160
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/24/2018
Initial Date Manufacturer Received 07/19/2018
Initial Date FDA Received08/06/2018
Supplement Dates Manufacturer Received09/20/2018
Supplement Dates FDA Received09/26/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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