FDA Adverse Event
Malfunction
Summary report: N
4.0MM AGGRESSIVE PLUS CUTTER, FORMULA (5BX)
MDR report key: 2050034
·
Received March 14, 2011
Report
- Report Number
- 2648666-2011-00067
- Event Type
- Malfunction
- Date Received
- March 14, 2011
- Date of Event
- February 25, 2011
- Report Date
- February 25, 2011
- Manufacturer
- STRYKER ENDOSCOPY PUERTO RICO
- Product Code
- HRX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING SURGERY, THE BLADE ON THE UNIT BROKE INTO TWO PIECES AT THE DISTAL END. IT WAS FURTHER REPORTED THAT ANOTHER UNIT FROM THE SAME LOT WAS USED TO FINISH THE SURGERY. THE PATIENT WAS NOT HARMED AND THE SURGERY WAS FINISHED WITH A SLIGHT DELAY OF 5 MINUTES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 4.0MM AGGRESSIVE PLUS CUTTER, FORMULA (5BX) | CUTTER | HRX | STRYKER ENDOSCOPY PUERTO RICO | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |