FDA Adverse Event
Summary report: N
*
MDR report key: 2890500
·
Received December 21, 2012
Report
- Report Number
- 2890500
- Date Received
- December 21, 2012
- Date of Event
- December 13, 2012
- Report Date
- December 21, 2012
- Manufacturer
- SURETEK MEDICAL
- Product Code
- NUJ
- Report Source
- User Facility report
- Reporter Location
- CO, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
THE SURGEON REPORTED THE REPROCESSED ENDOWASH DOES NOT SEEM TO BE SITTING SNUGGLY ON THE SCOPE AND THE LIP OF THE ENDOWASH IS VISIBLE ON THE MONITORS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | * | ENDOSCOPE, ACCESSORY | NUJ | SURETEK MEDICAL | * | 00120986 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR |