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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 544965
Device Problems Entrapment of Device (1212); Difficult to Remove (1528)
Patient Problem No Information (3190)
Event Date 05/18/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device has not been returned for investigation at this time.The manufacturer will continue to monitor and trend related events.
 
Event Description
During use the applier stuck in the closed position intra-abdominal on the cystic duct and was not possible to re-open it or remove it.The cystic duct had to be cut around the applier.The patient's condition was reported as unknown.
 
Manufacturer Narrative
(b)(4).Since this instrument was not returned for evaluation and lot information has not been provided, we are unable to determine where and when it was produced or perform a thorough dhr review at this time.Since the instrument was not returned for evaluation and pictures were not provided, we are unable to validate this complaint or determine root cause at this time.All instruments are thoroughly inspected and function tested at time of manufacture.
 
Event Description
During use the applier stuck in the closed position intra-abdominal on the cystic duct and was not possible to re-open it or remove it.The cystic duct had to be cut around the applier.The patient's condition was reported as unknown.
 
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Brand Name
HOL L 10MM ENDO APPLIER
Type of Device
APPLIER,SURGICAL, CLIP
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
Manufacturer (Section G)
TELEFLEX MEDICAL
3015 carrington mill blvd
morrisville NC 27560
Manufacturer Contact
jasmine brown
3015 carrington mill blvd
morrisville, NC 27560
9193614124
MDR Report Key6036357
MDR Text Key57713208
Report Number3011137372-2016-00309
Device Sequence Number1
Product Code GDO
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 09/28/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/18/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number544965
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/22/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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