FDA Adverse Event
Malfunction
Summary report: N
CANADY HYBRID PLASMA SCALPEL
MDR report key: 14206882
·
Received April 25, 2022
Report
- Report Number
- MW5109352
- Event Type
- Malfunction
- Date Received
- April 25, 2022
- Date of Event
- April 8, 2022
- Report Date
- April 11, 2022
- Manufacturer
- US MEDICAL INNOVATIONS, LLC.
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MN, US
- Reporter Occupation
- 501
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
CANADY TIP COMES APART FROM HANDPIECE WHILE IN USE. COMPANY HAS BEEN CONTACTED SEVERAL TIMES REGARDING THIS ISSUE. THIS IS OUR 6TH OCCURRENCE OF SAME ISSUE IN THE LAST 6 WEEKS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 970881 | CANADY HYBRID PLASMA SCALPEL | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GEI | US MEDICAL INNOVATIONS, LLC. | 0007-5554-22 | ||
| 970882 | CANADY HYBRID PLASMA SCALPEL | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GEI | US MEDICAL INNOVATIONS, LLC. | |||
| 970883 | CANADY HYBRID PLASMA SCALPEL | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GEI | US MEDICAL INNOVATIONS, LLC. | |||
| 970884 | CANADY HYBRID PLASMA SCALPEL | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GEI | US MEDICAL INNOVATIONS, LLC. | |||
| 970885 | CANADY HYBRID PLASMA SCALPEL | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GEI | US MEDICAL INNOVATIONS, LLC. | |||
| 970886 | CANADY HYBRID PLASMA SCALPEL | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GEI | US MEDICAL INNOVATIONS, LLC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Female |