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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HEM-O-LOK XL ENDO 10, APPLIER; APPLIER, SURGICAL, CLIP
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TELEFLEX MEDICAL HEM-O-LOK XL ENDO 10, APPLIER; APPLIER, SURGICAL, CLIP Back to Search Results
Catalog Number 544990
Device Problems Premature Activation (1484); Difficult to Open or Close (2921)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/21/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The facility has communicated that the device is not available for evaluation.Teleflex will continue to monitor and trend related events.
 
Event Description
After the ligation on renal artery, when the user released pressure on the trigger and the jaws were returned to a reset position, it was found that the clip had not locked completely and the clip fell off the applier and into the patient.The fallen clip in the patient was immediately removed and the procedure was continued without a problem.The patient's condition was reported as fine.
 
Manufacturer Narrative
(b)(4).The dhr for the instrument in question, was reviewed and found complete without any irregularities.This instrument was manufactured at the tecomet, inc.Kenosha facility as part of a 50pc.Lot in september of 2015.Since the instrument was not returned for evaluation we are unable to validate this complaint or determine root cause.All instruments are thoroughly inspected and function tested at time of manufacture.No corrective action required at this time.
 
Event Description
After the ligation on renal artery, when the user released pressure on the trigger and the jaws were returned to a reset position, it was found that the clip had not locked completely and the clip fell off the applier and into the patient.The fallen clip in the patient was immediately removed and the procedure was continued without a problem.The patient's condition was reported as fine.
 
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Brand Name
HEM-O-LOK XL ENDO 10, 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 Key6785373
MDR Text Key82785630
Report Number3011137372-2017-00248
Device Sequence Number1
Product Code GDO
Combination Product (y/n)N
Reporter Country CodeJA
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 07/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/10/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number544990
Device Lot Number06C1515977
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/08/2017
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
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