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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HOL L 10MM ENDO APPLIER; APPLIER, SURGICAL, CLIP
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TELEFLEX MEDICAL HOL L 10MM ENDO APPLIER; APPLIER, SURGICAL, CLIP Back to Search Results
Catalog Number 544995
Device Problem Activation, Positioning or Separation Problem (2906)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/05/2021
Event Type  malfunction  
Manufacturer Narrative
Qn# (b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
 
Event Description
The user was unable to load a clip properly during an operation.Therefore, a new unit was used instead.The sales rep.Received the applier and tested it; although he managed to load a clip, he felt a difficulty.Also, the opening and closing of the jaws seemed to be narrower than usual.The applier was purchased by the hospital in (b)(6) 2021.
 
Event Description
The user was unable to load a clip properly during an operation.Therefore, a new unit was used instead.The sales rep.Received the applier and tested it; although he managed to load a clip, he felt a difficulty.Also, the opening and closing of the jaws seemed to be narrower than usual.The applier was purchased by the hospital in (b)(6) 2021.
 
Manufacturer Narrative
(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-piece lot in december of 2019.Evaluation of the returned instrument shows that both the knob rotation and handle to jaw mechanisms are dry and sluggish feeling signifying they are in need of proper lubrication.We are able to validate this complaint.After the initial evaluation this instrument was lubricated using non-silicone-based instrument lube as recommended in ifu l02425 r01 which was supplied with the instrument at time of manufacture and both the knob rotation and handle to jaw mechanisms were returned to their normal free feeling status.Function testing shows that this instrument is now freely able to pick- up, retain, close and release multiple clips both with and without the use of silastic test tubing.Lack of proper lubrication prior to sterilization at the end users facility is suspected.
 
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Brand Name
HOL L 10MM ENDO APPLIER
Type of Device
APPLIER, SURGICAL, CLIP
Manufacturer (Section D)
TELEFLEX MEDICAL
morrisville NC
MDR Report Key12196883
MDR Text Key262459487
Report Number3011137372-2021-00178
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 07/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number544995
Device Lot Number06C1985963
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/20/2021
Date Manufacturer Received08/27/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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