FDA Adverse Event
Malfunction
Summary report: N
50-S XL
MDR report key: 2910539
·
Received December 3, 2012
Report
- Report Number
- 2648666-2012-00371
- Event Type
- Malfunction
- Date Received
- December 3, 2012
- Date of Event
- November 5, 2012
- Report Date
- November 7, 2012
- Manufacturer
- STRYKER ENDOSCOPY PUERTO RICO
- Product Code
- HRX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- NOT APPLICABLE
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 THAT THE SHEATH MELTED ON THE DISTAL TIP OF THE UNIT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 50-S XL | SERFAS PROBE | HRX | STRYKER ENDOSCOPY PUERTO RICO | 12203AE2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |