FDA Adverse Event
Malfunction
Summary report: N
ELITE & USA COLD KNIFE, STRIAGHT BLADE, 3/PKG
MDR report key: 1517028
·
Received October 13, 2009
Report
- Report Number
- 3006159227-2009-00006
- Event Type
- Malfunction
- Date Received
- October 13, 2009
- Date of Event
- June 6, 2009
- Report Date
- October 13, 2009
- Manufacturer
- GYRUS ACMI, INC.
- Product Code
- GDX
- PMA / PMN Number
- PREAMENDM
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
AT THE TIME OF THIS REPORT, THE DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION. AS A RESULT, A DETERMINATION CANNOT BE MADE AT THIS TIME. IF FURTHER INFO BECOMES AVAILABLE, GYRUS ACMI WILL CONTINUE THE INVESTIGATION AND UPDATE THE AGENCY ACCORDINGLY.
Description of Event or Problem · 1
DURING A SURGICAL PROCEDURE, THE DISTAL END OF THE ELITE COLD KNIFE DETACHED AND FELL INTO THE PT'S BODY. THE PIECE WAS RETRIEVED WITH NO PT HARM. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO FURTHER INCIDENTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ELITE & USA COLD KNIFE, STRIAGHT BLADE, 3/PKG | COLD KNIFE, STRAIGHT BLADE, 3/PKG | GDX | GYRUS ACMI, INC. | K-SB | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |