FDA Adverse Event
Malfunction
Summary report: N
USA SERIES ACN-1 FLEXIBLE CYSTONEPHROSCOPE
MDR report key: 230098
·
Received June 28, 1999
Report
- Report Number
- 1218764-1999-00012
- Event Type
- Malfunction
- Date Received
- June 28, 1999
- Date of Event
- June 24, 1999
- Report Date
- June 28, 1999
- Manufacturer
- CIRCON ACMI
- Product Code
- FAJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
REPORTEDLY, DURING SURGERY SOME "WRAPPING" ON SCOPE SHAFT CAME OFF IN PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | USA SERIES ACN-1 FLEXIBLE CYSTONEPHROSCOPE | CYSTOSCOPE | FAJ | CIRCON ACMI | ACN-1 | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO |