FDA Adverse Event
Injury
Summary report: N
HALL - ZIMMER
MDR report key: 215866
·
Received March 23, 1999
Report
- Report Number
- 215866
- Event Type
- Injury
- Date Received
- March 23, 1999
- Date of Event
- March 10, 1999
- Report Date
- March 23, 1999
- Manufacturer
- PACER MEDICAL CORPORATION
- Product Code
- DWH
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- NE, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
OSCILLATING SAW USED DURING CORONARY BYPASS PROCEDURE WAS LAYING ON STERILE FIELD ON PT. SAFETY BUTTON WAS NOT ON. WHEN AIR HOSE WAS ATTACHED THE SAW BEGAN TO OSCILLATE WITHOUT THE TRIGGER BEING DEPRESSED. THE SAW STRUCK PT ON THE LEFT MID CALF PRODUCING A 1 - 1 1/2 INCH LACERATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HALL - ZIMMER | SERIES 4 OSCILLATOR | DWH | PACER MEDICAL CORPORATION | 506702 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Hospitalization| R |