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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HEMOLOK TAKEAPART XL 10MM ENDO APPLIER; APPLIER,SURGICAL, CLIP
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TELEFLEX MEDICAL HEMOLOK TAKEAPART XL 10MM ENDO APPLIER; APPLIER,SURGICAL, CLIP Back to Search Results
Catalog Number 544990T
Device Problems Difficult To Position (1467); Unintended Movement (3026)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/24/2016
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
Alleged event: while performing a radical nephrectomy the hem-o-loc clip was applied to the renal artery.It was the first clip used during the procedure.As the surgeon was closing the clip, it slipped and the applier jaws sheared cutting the artery; a distinctive metallic sound was heard.The surgeon was able to clamp the artery with hem-o-loc clip using a different applier.The patient's condition was reported as fine.
 
Manufacturer Narrative
Qn#(b)(4).Dhr of the lot shows that the right material and components were used and that the instrument meets all specifications.All working steps are documented.Complaint instrument 544990t, lot 0848425-015 was received in (b)(4) and forwarded to the supplier for further investigation.The rotation knob is broken.Complaint could not be confirmed.No issue found.No further action taken in manufacturing.Supplier reported that they received instrument 544990t, lot 0848425 for investigation.The instrument has never been repaired before.Functional and dimensional tests were performed without any issues.The complaint could not be confirmed.The instrument can be refurbished.
 
Event Description
Alleged event: while performing a radical nephrectomy the hem-o-loc clip was applied to the renal artery.It was the first clip used during the procedure.As the surgeon was closing the clip, it slipped and the applier jaws sheared cutting the artery; a distinctive metallic sound was heard.The surgeon was able to clamp the artery with hem-o-loc clip using a different applier.The patient's condition was reported as fine.
 
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Brand Name
HEMOLOK TAKEAPART XL 10MM ENDO APPLIER
Type of Device
APPLIER,SURGICAL, CLIP
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
Manufacturer (Section G)
KMEDIC EUROPE GMBH, PILLING WECK,
gansacker 36
tuttlingen 78532
GM   78532
Manufacturer Contact
jasmine brown
3015 carrington mill blvd
morrisville, NC 27560
9193614124
MDR Report Key5531760
MDR Text Key41381514
Report Number3005236665-2016-00005
Device Sequence Number1
Product Code GDO
Combination Product (y/n)N
Reporter Country CodeSP
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 03/01/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number544990T
Device Lot Number0848425-015
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/14/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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