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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 02/06/2024
Event Type  malfunction  
Event Description
It was reported that "the jaws got bent when the user attempted to load a clip to the applier during a surgery.Therefore, the applier was replaced with a new one to complete the procedure.Nothing fell/remained in the patient and no patient injury occurred".
 
Manufacturer Narrative
(b)(4).N/a.Other remarks: n/a.Corrected data: n/a.
 
Manufacturer Narrative
(b)(4).The sample was returned to the manufacturer for investigation.The manufacturer reported: "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)-pc.Lot in december of 2022.It was found that this order was made from the correct materials and components and all approved processes were followed.It can then be stated that the alleged non-conformance inciting this complaint was not due to an error in tecomet - kenosha's manufacturing process.Evaluation of the returned instrument shows that both the knob rotation and handle to jaw mechanisms are very dry and sluggish feeling and in need of proper lubrication.Further evaluation shows that the jaws are slightly loose and misaligned and bent upward when in the closed position.There is visible damage found to the jaw pivot pin area on the outer tube assembly.We are able to validate this complaint for the returned instrument.After the initial evaluation this instrument was properly lubricated using non silicone based instrument lube as instructed in ifu l02425 r02 which was included with the ins trument at time of production and all of its mechanisms have been restored to free feeling movement.This instrument was then dis-assembled in order to evaluate its internal components and it was found that the inner drive rod is bent/damaged, and both of its bosses are damaged where they acuate the slots in the jaws.We suspect that the damaged drive rod bosses caused the jaws to be slightly loose and misaligned in the closed position and the bent drive rod caused the jaws to be in the upwards position when closed.We are unable to determine what caused the drive rod to become bent and damaged and for this instrument's mechanisms to be dry and sluggish but lack of proper lubrication and mishandling of this device at the end user's facility is suspected.All (b)(4) instruments from this lot were 100% visually inspected and properly lubricated 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." teleflex will continue to monitor and trend on complaints of this nature.
 
Event Description
It was reported that "the jaws got bent when the user attempted to load a clip to the applier during a surgery.Therefore, the applier was replaced with a new one to complete the procedure.Nothing fell/remained in the patient and no patient injury 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
bryanna connelly
3015 carrington mill blvd
morrisville 27560
MDR Report Key18810997
MDR Text Key337486264
Report Number3011137372-2024-00025
Device Sequence Number1
Product Code GDO
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 02/06/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/29/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number544965
Device Lot Number06F2250313
Was Device Available for Evaluation? Yes
Date Manufacturer Received02/06/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/22/2022
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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