FDA Adverse Event
Injury
Summary report: N
MEMORY SOFT STONE EXTRACTOR
MDR report key: 105829
·
Received July 1, 1997
Report
- Report Number
- 105829
- Event Type
- Injury
- Date Received
- July 1, 1997
- Date of Event
- May 29, 1997
- Report Date
- June 13, 1997
- Manufacturer
- WILSON-COOK
- Product Code
- FFL
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- NH, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
5/29/97 ERCP WITH ATTEMPTED CED CALCULUS REMOVAL. ONCE CALCULUS CAPTURED IN BASKET WIRE CABLE BROKE. PT. TO SURGERY FOR REMOVAL OF WIRE BASKET AND CALCULUS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MEMORY SOFT STONE EXTRACTOR | CED-STONE RETRIEVOR | FFL | WILSON-COOK | MSB-2XF-F | 691839 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR | Required Intervention |