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 |