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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 Loose or Intermittent Connection (1371)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/08/2022
Event Type  malfunction  
Event Description
It was reported that jaws of the applier were found broken when the user tried to ligate the cystic duct during the procedure.No fragments were fell/remained in the patient.Because of the applier condition, the user thought the applier could not be removed from a trocar, so it was removed together with the trocar.A new trocar and an applier were used to complete the procedure.There was no patient injury reported as a result of this issue.Based on the additional information on the associated complaint (b)(4), it states that the "jaws were bent and the pivot pin was l oose" there are two (2) defects on the same one (1) sample.
 
Manufacturer Narrative
Qn#(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
 
Manufacturer Narrative
(b)(4).The device history for the returned device was reviewed and found complete without any irregularities.This device was produced at the tecomet, inc.Kenosha wi facility as part of a (b)(4)-pc 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 device as received shows that the jaws are bent to the right and loose and misaligned to each other in the closed position and the jaw pivot pin is pullled through one side of the bent/damaged outer tube assembly.We are able to validate this complaint.After the initial evaluation this instrument was dis-assembled in order to evaluate its internal components and it was found that the inner drive rod is bent where it engages that jaws and its bosses are also both damaged where they engage the jaws.We suspect that the damaged drive rod bosses caused the jaws to become slightly loose and misaligned.We are unable to determine what caused the jaws to be bent to the right and for the drive rod and it's bosses to be damaged and for the jaw pivot pin to be pulled through one side of the bent/damaged outer tube assembly 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 jaws of the applier were found broken when the user tried to ligate the cystic duct during the procedure.No fragments were fell/remained in the patient.Because of the applier condition, the user thought the applier could not be removed from a trocar, so it was removed together with the trocar.A new trocar and an applier were used to complete the procedure.There was no patient injury reported as a result of this issue.Based on the additional information on the associated complaint (b)(4), it states that the "jaws were bent and the pivot pin was l oose" there are two (2) defects on the same one (1) sample.
 
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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
3015 carrington mill blvd
morrisville NC 27560
Manufacturer Contact
effie jefferson
3015 carrington mill blvd
morrisville 27560
9194332672
MDR Report Key15952215
MDR Text Key307783768
Report Number3011137372-2022-00239
Device Sequence Number1
Product Code GDO
UDI-Device Identifier14026704696816
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 12/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/09/2022
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? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/17/2023
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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