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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 Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/15/2023
Event Type  malfunction  
Event Description
It was reported that the jaws of the applier got bent during a surgery.Therefore, it was replaced with a new unit to complete the procedure.Nothing fell/remained in the patient and no injury to the patient occurred.
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
(b)(4) the sample was returned and sent to the manufacturer (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 (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 shows that the jaws are loose and misaligned to each other and the bent to the right and the jaw pivot pin is pulled thru one side of the bent/damaged outer tube assembly.We are able to validate this complaint for this device.As received this device is complete and is not missing any of its components.This instrument was dis-assembled in order to evaluate its internal components by removing the luer flush port and it was found that the inner drive rod (n00185) is bent, and its bosses are both damaged where they engage the jaws.We suspect that the damaged drive rod bosses caused the jaws to become slightly loose and misaligned in the closed position.We are unable to determine what caused the drive rod to become bent to the right, and for its bosses to become damaged and the for the jaws to be bent to the right 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.".
 
Event Description
It was reported that the jaws of the applier got bent during a surgery.Therefore, it was replaced with a new unit to complete the procedure.Nothing fell/remained in the patient and no injury to the patient occurred.
 
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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 Key16683082
MDR Text Key312871424
Report Number3011137372-2023-00071
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 03/15/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/05/2023
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 Number06A2244666
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received05/15/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/03/2022
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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