FDA Adverse Event
Other
Summary report: N
SNOWDEN PENCER
MDR report key: 16840
·
Received August 16, 1994
Report
- Report Number
- 16840
- Event Type
- Other
- Date Received
- August 16, 1994
- Date of Event
- August 12, 1994
- Report Date
- August 12, 1994
- Manufacturer
- SNOWDEN-PENCER
- Product Code
- GEI
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MO, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
SCRUB NURSE DISCOVERED 1 CM PORTION OF INSULATION OFF OF ELECTROSURGICAL DISSECTER APPROXIMATELY 4 INCHES UP FROM CAUTERY TIP. SURGEON NOTIFIED THAT INSTRUMENT COULD NOT BE USED AND WHY; REPLY "THAT MUST BE HOW SHE GOT THE BURN ON HER ABDOMEN". BURN LOCATED LLQ 4MM X 2MM SUTURED PER SURGEON.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SNOWDEN PENCER | ELECTROSURGICAL DISSECTOR | GEI | SNOWDEN-PENCER |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Other |