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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HOL ML 5 MILLIMETER ENDO APPLIER; APPLIER, SURGICAL, CLIP
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TELEFLEX MEDICAL HOL ML 5 MILLIMETER ENDO APPLIER; APPLIER, SURGICAL, CLIP Back to Search Results
Catalog Number 544965
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Patient Involvement (2645)
Event Date 07/29/2019
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
It was reported that the user found that the pivot pin of the applier was loose and almost detached before use.Therefore, it was replaced with a new one.The applier was purchased by the hospital within 5 months.
 
Event Description
It was reported that the user found that the pivot pin of the applier was loose and almost detached before use.Therefore, it was replaced with a new one.The applier was purchased by the hospital within 5 months.
 
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 (b)(4) pc.Lot in (b)(6)2018.The returned instrument was evaluated and found that as arrived the jaw is loose from the instrument and it was not returned with the other jaw and jaw pivot pin.The outer tube assembly is bent open/damaged at the jaw end thus we are able to validate this complaint.Since the instrument was returned as damaged it is suspected that it was mishandled al the end user's facility.All (b)(4) instruments from this lot were 100% visually inspected and function tested prior to shipment to customer as this is a standardized process at this facility for this product line.
 
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Brand Name
HOL ML 5 MILLIMETER ENDO APPLIER
Type of Device
APPLIER, SURGICAL, CLIP
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
MDR Report Key8910888
MDR Text Key154907427
Report Number3011137372-2019-00254
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,u
Type of Report Initial,Followup
Report Date 07/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number544965
Device Lot Number06A1863111
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/29/2019
Date Manufacturer Received09/16/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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