FDA Adverse Event
Other
Summary report: N
MICROVASIVE
MDR report key: 385464
·
Received March 27, 2002
Report
- Report Number
- 385464
- Event Type
- Other
- Date Received
- March 27, 2002
- Date of Event
- March 2, 2002
- Report Date
- March 27, 2002
- Manufacturer
- MICROVASIVE
- Product Code
- KNS
- Report Source
- User Facility report
- Reporter Location
- GA, US
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
GOLD PROBE WITH INJECTION NEEDLE DEPLOYED FROM END OF ENDOSCOPE, ENTIRE GOLD PROBE AND "BLACK WASHER" DEPLOYED OFF OF THE PROBE INTO PT. ANOTHER PROBE (GOLD 7 FR WITH INJ) USED, WOULD NOT RETACT BACK. ENTIRE SCOPE WITH PROBE REMOVED AND PACKAGING RETAINED. NO HARM TO PT. WILL PASS THROUGH GI TRACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MICROVASIVE | GOLDEN PROBE | KNS | MICROVASIVE | UPNM00560150 | 4479621 | |
| 2 | MICROVASIVE | GOLDEN PROBE | KNS | MICROVASIVE | UPNM00560150 | 3867717 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Other |