FDA Adverse Event
Malfunction
Summary report: N
4.0MM AGGRESSIVE PLUS CUTTER, FORMULA (5BX)
MDR report key: 2111056
·
Received May 18, 2011
Report
- Report Number
- 2648666-2011-00142
- Event Type
- Malfunction
- Date Received
- May 18, 2011
- Date of Event
- April 28, 2011
- Report Date
- April 29, 2011
- Manufacturer
- STRYKER ENDOSCOPY PUERTO RICO
- Product Code
- HRX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ADD'L INFO WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHEN THE DR PUT THE BLADE OF THE PRODUCT IN PLACE AT THE START OF THE PROCEDURE, HE OBSERVED THAT THERE WAS METAL ABRASION FROM THE BLADE AND AFTERWARDS IT BROKE. IT WAS FURTHER REPORTED THAT THE BROKEN PIECE WAS REMOVED FROM THE PT AND THE PROCEDURE WAS COMPLETED USING ANOTHER BLADE.
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 | 11017CE2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |