FDA Adverse Event
Malfunction
Summary report: N
CANADY HYBRID PLASMA SCALPEL
MDR report key: 14111229
·
Received April 13, 2022
Report
- Report Number
- MW5108963
- Event Type
- Malfunction
- Date Received
- April 13, 2022
- Date of Event
- March 29, 2022
- Report Date
- March 29, 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
TIP OF THE CANADY HANDPIECE CAME UNATTACHED DURING THE CASE. SURGEON WAS ABLE TO REATTACH IT AND CONTINUE USING. COMPANY NOTIFIED OF ISSUE. REPLACED 5 HANDPIECES. WE HAVE CONTINUED TO HAVE THIS ISSUE. THIS IS THE 5TH OCCURRENCE OF THIS SAME ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2415866 | CANADY HYBRID PLASMA SCALPEL | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GEI | US MEDICAL INNOVATIONS LLC. | |||
| 2415867 | CANADY HYBRID PLASMA SCALPEL | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GEI | US MEDICAL INNOVATIONS LLC. | |||
| 2415868 | CANADY HYBRID PLASMA SCALPEL | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GEI | US MEDICAL INNOVATIONS LLC. | |||
| 2415869 | CANADY HYBRID PLASMA SCALPEL | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GEI | US MEDICAL INNOVATIONS LLC. | |||
| 2415870 | CANADY HYBRID PLASMA SCALPEL | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GEI | US MEDICAL INNOVATIONS LLC. | 0007-5554-22 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Male |