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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 Activation, Positioning or Separation Problem (2906)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/15/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
 
Event Description
The user was able to load clips at first during a surgery, however, the jaws of the applier gradually did not open enough so that he/she was not able to load the remaining 2 clips.Therefore, the applier and the clip were replaced with a new unit to complete the surgery.
 
Manufacturer Narrative
Qn# (b)(4).The dhr for the returned instrument was reviewed and found completely without any irregularities.This instrument was produced at the tecomet , inc.Kenosha, wi facility as part of a 50 pc.Lot in march of 2020.Evaluation of the returned instrument shows that the handle to jaw and knob rotation mechanisms are both dry and sluggish feeling and the open jaw gap is slightly undersized thus we are able to validate this complaint.We are unable to determine what caused the open jaw gap to be undersized and for the jaw mechanism and knob rotation mechanisms to become dry and sluggish but lack of proper lubrication 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.
 
Event Description
The user was able to load clips at first during a surgery, however, the jaws of the applier gradually did not open enough so that he/she was not able to load the remaining 2 clips.Therefore, the applier and the clip were replaced with a new unit to complete the surgery.
 
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Brand Name
HOL ML 5MM ENDO APPLIER
Type of Device
APPLIER, SURGICAL, CLIP
Manufacturer (Section D)
TELEFLEX MEDICAL
morrisville NC
MDR Report Key11604192
MDR Text Key243728483
Report Number3011137372-2021-00073
Device Sequence Number1
Product Code GDO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 03/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number544965
Device Lot Number06F1989611
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/20/2021
Date Manufacturer Received05/10/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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