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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 Device Dislodged or Dislocated (2923)
Patient Problems No Consequences Or Impact To Patient (2199); Blood Loss (2597)
Event Date 12/13/2018
Event Type  Injury  
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 a vessel was ligated with some ml sized clips using ml endo applier.The vessel was divided successfully.However, after the procedure of the pelvic inner cavity was finished, mini-laparotomy was performed, and it was found that the clips had come off the vessel and severe bleeding occurred in the abdominal cavity and hemostatic therapy was performed on the patient.
 
Manufacturer Narrative
(b)(4).The dhr for the returned instrument was reviewed and found completely without any irregularities.This instrument was produced at the tecomet, inc kenosha facility as part of a 50 pc.Lot in march of 2015.The returned instrument was evaluated and found that the luer flush port cap is missing as received and the knob rotation and handle to jaw mechanisms are dry and sluggish suggesting that this instrument is in need of lubrication.Further evaluation showed that one of the jaws was slightly damaged at the tip but this did not affect the eye hole that the clip is retained in.The jaws were slightly loose and misaligned to each other in the closed position.Although the tips were slightly misaligned this instrument was function tested using silastic test tubing as used at time of manufacture and it was able to pick up, retain and close and release multiple clips over the test tubing and none of the clips fell off the tubing.We are unable to validate this complaint since we are unable to replicate the alleged issue.We are unable to determine what caused the alleged issue but it is suspected that since the handle to jaw and knob rotation mechanisms were dry and sluggish that this instrument was not properly lubricated prior to sterilization prior to procedure as stated in ifu l06109 r02 which came with the instrument which states "the instrument must be cleaned, lubricated , functionally checked and sterilized prior to each use.Use a non-silicone, water-based lubricant prior to sterilization.All instruments are 100% visually inspected and function tested prior to shipment to customer as this is a standardized procedure for this product line at this facility.
 
Event Description
It was reported that a vessel was ligated with some ml sized clips using ml endo applier.The vessel was divided successfully.However, after the procedure of the pelvic inner cavity was finished, mini-laparotomy was performed, and it was found that the clips had come off the vessel and severe bleeding occurred in the abdominal cavity and hemostatic therapy was performed on the patient.
 
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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 Key8223103
MDR Text Key132264937
Report Number3011137372-2019-00003
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 12/13/2018
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 Number06B1498886
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/22/2019
Initial Date Manufacturer Received 12/13/2018
Initial Date FDA Received01/07/2019
Supplement Dates Manufacturer Received02/05/2019
Supplement Dates FDA Received02/07/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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