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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HOL ML 5MM ENDO APPLIER; CLIP, IMPLANTABLE
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TELEFLEX MEDICAL HOL ML 5MM ENDO APPLIER; CLIP, IMPLANTABLE Back to Search Results
Model Number IPN915189
Device Problem Activation, Positioning or Separation Problem (2906)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/11/2021
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
It was reported that, when the user attempted to ligate a clip during a surgery, it got stuck in the applier.The user put the applier and the clip out of the patient body and took the clip out of the applier with a forceps.The surgery was completed with a new applier and clips.
 
Event Description
It was reported that, when the user attempted to ligate a clip during a surgery, it got stuck in the applier.The user put the applier and the clip out of the patient body and took the clip out of the applier with a forceps.The surgery was completed with a new applier and clips.
 
Manufacturer Narrative
Qn# (b)(4).Tc#1900083514 was incorrectly created (as it was a complaint for applier.A corrected tc#20038855 was created and submitted for this complaint, and 1900083514 was voided.Please make a note of it for your records.
 
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Brand Name
HOL ML 5MM ENDO APPLIER
Type of Device
CLIP, IMPLANTABLE
Manufacturer (Section D)
TELEFLEX MEDICAL
morrisville NC
MDR Report Key11581019
MDR Text Key242762344
Report Number3011137372-2021-00071
Device Sequence Number1
Product Code FZP
UDI-Device Identifier24026704696813
UDI-Public24026704696813
Combination Product (y/n)N
PMA/PMN Number
K133202
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 03/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2021
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 Number06C1749060
Was Device Available for Evaluation? Yes
Date Manufacturer Received03/11/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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