FDA Adverse Event Malfunction Summary report: N

SURE GRIP TISSUE GRASPER

MDR report key: 3919014 · Received June 27, 2014

Report

Report Number
1833053-2014-00002
Event Type
Malfunction
Date Received
June 27, 2014
Date of Event
June 10, 2014
Report Date
June 26, 2014
Manufacturer
G. HIPP AND SOHN
Product Code
HXT
Product Problem
Yes
Report Source
Distributor report
Reporter Location
JA
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

SPIKE OF SURE GRIP SOFT TISSUE GRASPER FELL OFF DURING THE SECOND USE. THE SPIKE WAS SEQUESTERED. NO INJURIES WERE SUSTAINED BY THE PATIENT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
376468 SURE GRIP TISSUE GRASPER RONGUER/GRASPER HXT G. HIPP AND SOHN 3645-02 0512GH

Patients

Seq Age Sex Outcome Treatment
1