FDA Adverse Event
Injury
Summary report: N
ENDOCATCH GOLD 10MM
MDR report key: 6020476
·
Received October 7, 2016
Report
- Report Number
- MW5065322
- Event Type
- Injury
- Date Received
- October 7, 2016
- Date of Event
- September 13, 2016
- Report Date
- October 7, 2016
- Manufacturer
- COVIDIEN
- Product Code
- GCJ
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- NY, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
PIECE OF PLASTIC ON PROBE USED WITH BONE STIMULATOR FELL OFF DURING USE. PIECE RETRIEVED IMMEDIATELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 664159 | ENDOCATCH GOLD 10MM | BONE STIMULATOR | GCJ | COVIDIEN | 3303 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Required Intervention |