FDA Adverse Event
Other
Summary report: N
COLD KNIFE, STRAIGHT BLADE, 3/PKG
MDR report key: 1981377
·
Received February 3, 2011
Report
- Report Number
- 3006159227-2011-00001
- Event Type
- Other
- Date Received
- February 3, 2011
- Date of Event
- January 3, 2011
- Report Date
- February 3, 2011
- Manufacturer
- GYRUS ACMI, INC
- Product Code
- GDX
- PMA / PMN Number
- PREAMEND
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
PERFORMANCE REPORT, NO DEVICE IS BEING RETURNED; THEREFORE WE CANNOT DETERMINE THE FAILURE MODE OF THE REPORTED INCIDENT. WE WILL MONITOR THE COMPLAINT DATABASE FOR FURTHER OCCURRENCES. IF FURTHER INFO BECOMES AVAILABLE, GYRUS (B)(4) WILL CONTINUE THE INVESTIGATION AND UPDATE THE AGENCY ACCORDINGLY.
Description of Event or Problem · 1
DURING A SURGICAL PROCEDURE WHILE USING THE ELITE COLD KNIFE STRAIGHT BLADE, THE BLADE BROKE OFF IN THE PT. THE SURGEON WAS ABLE TO RETRIEVE THE BLADE WITHOUT HARMING THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COLD KNIFE, STRAIGHT BLADE, 3/PKG | COLD KNIFE, STRAIGHT BLADE, 3/PKG | GDX | GYRUS ACMI, INC | K-SB | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |