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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
Catalog Number 544965
Device Problem Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/04/2023
Event Type  malfunction  
Event Description
It was reported that the jaws of the applier got bent and the pivot pin got detached from the applier during use.Therefore, the applier was replaced with a new one to complete the procedure.Nothing fell/remained in the patient and no patient injury occurred.The patient status is reported as "fine".
 
Manufacturer Narrative
Qn#: (b)(4).Other remarks: n/a.Corrected data: n/a.
 
Event Description
It was reported that the jaws of the applier got bent and the pivot pin got detached from the applier during use.Therefore, the applier was replaced with a new one to complete the procedure.Nothing fell/remained in the patient and no patient injury occurred.The patient status is reported as "fine".
 
Manufacturer Narrative
(b)(4).The device was returned and sent to the manufacturing site (tecomet) for investigation.Tecomet reports "the dhr 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 50-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 instrument shows that the jaws are loose and misaligned and bent towards the left, and the jaw pivot pin is pulled thru one side of the bent/damaged outer tube assembly.We are able to validate the complaint for the returned instrument.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 (n00185) bosses is damaged where it engages the jaws.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 and for the jaw pivot pin to be pulled thru one side of the bent/damaged outer tube assembly but mishandling of this device at the end user's facility is suspected.All 50 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.".
 
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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
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
MDR Report Key17409683
MDR Text Key320253654
Report Number3011137372-2023-00195
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,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 07/11/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number544965
Device Lot Number06A2244654
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received10/02/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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