FDA Adverse Event
Malfunction
Summary report: N
4.0 MM TOMCAT CUTTER, FORMULA (5BX)
MDR report key: 2063322
·
Received April 11, 2011
Report
- Report Number
- 2648666-2011-00102
- Event Type
- Malfunction
- Date Received
- April 11, 2011
- Date of Event
- March 30, 2011
- Report Date
- March 30, 2011
- Manufacturer
- STRYKER ENDOSCOPY PUERTO RICO
- Product Code
- HRX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THE CUTTER UNIT FLAKED DURING A CASE. IT WAS FURTHER REPORTED THAT THE PARTICLES WERE NOTICEABLE TO THE DOCTOR. FURTHER IT DID NOT DELAY THE CASE NOR WERE THERE ANY ADVERSE AFFECTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 4.0 MM TOMCAT CUTTER, FORMULA (5BX) | CUTTER | HRX | STRYKER ENDOSCOPY PUERTO RICO | 10334CE2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |