FDA Adverse Event
Malfunction
Summary report: N
3.4MM 90 LEFT ROTARY PUNCH
MDR report key: 2112661
·
Received April 29, 2011
Report
- Report Number
- 2936485-2011-00272
- Event Type
- Malfunction
- Date Received
- April 29, 2011
- Date of Event
- March 20, 2011
- Report Date
- April 2, 2011
- Manufacturer
- STRYKER ENDOSCOPY SAN JOSE
- Product Code
- NBH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MX
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFO WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE UNIT INVOLVED HAD CORROSION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 3.4MM 90 LEFT ROTARY PUNCH | PUNCH | NBH | STRYKER ENDOSCOPY SAN JOSE | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |