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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HZ APPLIER MED 8" CVD
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TELEFLEX MEDICAL HZ APPLIER MED 8" CVD Back to Search Results
Catalog Number 237081
Device Problem Separation Failure (2547)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/01/2015
Event Type  malfunction  
Event Description
Complaint alleges: the appliers are picking up the clips from the cartridges with no issues, but when the surgeon attempts to use the applier the clips are 'sticking' in the jaws.The procedure was an image guided wide local excision of the breast and lymph node biopsy.The pt condition is fine with no medical consequence, as a result of the incident.The procedure completed using a different applier.No pt injury reported.
 
Manufacturer Narrative
Qn# (b)(4).The device sample was not received by the mfr at the time of this report.
 
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Brand Name
HZ APPLIER MED 8" CVD
Type of Device
APPLIER
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
Manufacturer (Section G)
TELEFLEX MEDICAL
2917 weck dr.
research triangle park NC 27709
Manufacturer Contact
jasmine brown
3015 carrington mill blvd.
morrisville, NC 27560
9193614124
MDR Report Key4627815
MDR Text Key5659678
Report Number1044475-2015-00144
Device Sequence Number1
Product Code GEF
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 02/24/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Other
Device Catalogue Number237081
Device Lot Number06A1378696
Was Device Available for Evaluation? Yes
Date Manufacturer Received02/24/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Type of Device Usage Unknown
Patient Sequence Number1
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