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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HZ APPLIER MED 8" CVD; APPLIER, SURGICAL, CLIP
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TELEFLEX MEDICAL HZ APPLIER MED 8" CVD; APPLIER, SURGICAL, CLIP Back to Search Results
Model Number IPN004607
Device Problem Mechanical Jam (2983)
Patient Problems Tissue Damage (2104); No Information (3190)
Event Date 11/28/2019
Event Type  Injury  
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 clip was stuck in the applier.Clinical consequences: a vessel was ripped.The patient's condition is currently unknown.
 
Event Description
It was reported that the clip was stuck in the applier.Clinical consequences: a vessel was ripped.The patient's condition is currently unknown.
 
Manufacturer Narrative
(b)(4).Per information provided from customer we are unable to perform a thorough dhr review at this time since lot information has not been provided.The alleged instrument has not been returned for review or evaluation therefore we are unable to validate the alleged complaint.All instruments produced at this facility are 100% visually inspected and function tested prior to release to customer as this is a standardized procedure at this facility for this product line.
 
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Brand Name
HZ APPLIER MED 8" CVD
Type of Device
APPLIER, SURGICAL, CLIP
Manufacturer (Section D)
TELEFLEX MEDICAL
morrisville NC
MDR Report Key9489467
MDR Text Key173651719
Report Number3011137372-2019-00427
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 12/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberIPN004607
Device Catalogue Number237081
Was Device Available for Evaluation? No
Date Manufacturer Received02/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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