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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HOL ML 5MM ENDO APPLIER; APPLIER, SURGICAL, CLIP
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TELEFLEX MEDICAL HOL ML 5MM ENDO APPLIER; APPLIER, SURGICAL, CLIP Back to Search Results
Model Number IPN915189
Device Problem Mechanical Jam (2983)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/25/2022
Event Type  malfunction  
Manufacturer Narrative
Qn#(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 the clip got stuck and did not leave the applier after ligation during a surgery.Therefore, the user replaced the applier with a new unit to complete the operation.No clip fell/remained in the patient.There was no reported injury.
 
Manufacturer Narrative
(b)(4).The sample was returned and sent to the manufacturing site (tecomet) for investigation.Tecomet reports "the ohr for the returned instrument was reviewed and found complete without any irregularities.This instrument was produced at the tecomet, inc.Kenosha, wi facility as part of a (b)(4).Lot in march of 2022.It was found that this order was made from the correct materials and components and all approved processes were followed.Evaluation of the returned instrument as received shows that the handle to jaw mechanism is free and not binding or sluggish in any way.Visual examination shows that there is no external damage to the jaws or the jaw pivot pin area on the outer tube assembly, but the jaws are slightly loose and misaligned in the closed position.Functional testing shows that this instrument is able to pick-up, retain, close, and release multiple clips both with and without the use of the silastic test tubing.After the initial evaluation this instrument was dis-assembled in order to evaluate its internal components and it was found that one of the inner drive rod bosses is damaged where it engages the slot in the jaw.There was no damage found to the exterior surfaces on the drive rod coupling.We suspect that the damaged drive rod boss caused the jaws to become slightly loose and misaligned in the closed position.We are unable to determine what caused the drive rod boss to become damaged but mishandling of this device at the end user's facility is suspected.All (b)(4) instruments from this lot were 100% visually inspected and function tested prior to shipment to the customer as this is a standardized procedure at this facility for this product line.Due to these findings, no further actions will be taken in response to this complaint and this record will be deemed closed.".
 
Event Description
It was reported that the clip got stuck and did not leave the applier after ligation during a surgery.Therefore, the user replaced the applier with a new unit to complete the operation.No clip fell/remained in the patient.There was no reported injury.
 
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Brand Name
HOL ML 5MM ENDO APPLIER
Type of Device
APPLIER, SURGICAL, CLIP
Manufacturer (Section D)
TELEFLEX MEDICAL
morrisville NC
Manufacturer (Section G)
TELEFLEX MEDICAL
rancho el descanso
tecate 21478
MX   21478
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194332672
MDR Report Key15885945
MDR Text Key306445867
Report Number3003898360-2022-00806
Device Sequence Number1
Product Code GDO
UDI-Device Identifier24026704696813
UDI-Public24026704696813
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/30/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberIPN915189
Device Catalogue Number544965
Device Lot Number06A2244658
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/24/2023
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage A
Patient Sequence Number1
Treatment
NONE REPORTED; NONE REPORTED
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