FDA Adverse Event
Injury
Summary report: N
*
MDR report key: 316090
·
Received February 12, 2001
Report
- Report Number
- MW1021067
- Event Type
- Injury
- Date Received
- February 12, 2001
- Date of Event
- January 30, 2001
- Report Date
- February 12, 2001
- Manufacturer
- VANGUARD
- Product Code
- GCJ
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
LAPAROSCOPIC REMOVAL OF BOTH OVARIES AND TUBES. DURING CASE A VANGUARD, JCN-283107 REPROCESSED ENDOCATH MADE BY AUTOSUTURE, CAT# 173050, SEPARATED INSIDE ABDOMEN. DR WAS ABLE TO RETRIEVE DEVICE IN TOTAL. IF DR WAS UNABLE TO RETRIEVE, A LAPAROTOMY WOULD HAVE BEEN PERFORMED. PT FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 5315 | * | ENDOCATCH | GCJ | VANGUARD | * | 173050 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Required Intervention |