FDA Adverse Event
Malfunction
Summary report: N
CANADY HYBRID PLASMA SCALPEL
MDR report key: 14358865
·
Received May 10, 2022
Report
- Report Number
- MW5109627
- Event Type
- Malfunction
- Date Received
- May 10, 2022
- Date of Event
- April 26, 2022
- Report Date
- April 27, 2022
- Manufacturer
- US MEDICAL INNOVATIONS
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
TWO CANADY HANDPIECES (SAME LOT) DID NOT ALLOW ARGON GAS TO FLOW THROUGH. TANK WAS CHECKED AND WAS FULL. SWITCHED TO A DIFFERENT HANDPIECE (85 MM PADDLE) AND IT WORKED AS IT SHOULD. ON THE SAME DAY, TWO OTHER HANDPIECES HAD ISSUE WITH TIP NOT STAYING ATTACHED. WE HAVE HAD THIS PROBLEM REPEATEDLY OVER LAST 6-8 WEEKS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 870964 | CANADY HYBRID PLASMA SCALPEL | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GEI | US MEDICAL INNOVATIONS | AW-422552 | 0010-S552-22 | |
| 872040 | CANADY HYBRID PLASMA SCALPEL | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GEI | US MEDICAL INNOVATIONS | AW-422552 | 0010-S552-22 | |
| 872041 | CANADY HYBRID PLASMA SCALPEL | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GEI | US MEDICAL INNOVATIONS | |||
| 872042 | CANADY HYBRID PLASMA SCALPEL | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GEI | US MEDICAL INNOVATIONS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |