FDA Adverse Event
Malfunction
Summary report: N
VCARE PLUS UTERINE MANIPULATOR
MDR report key: 11284927
·
Received February 5, 2021
Report
- Report Number
- 11284927
- Event Type
- Malfunction
- Date Received
- February 5, 2021
- Date of Event
- January 29, 2021
- Report Date
- February 1, 2021
- Manufacturer
- CONMED CORPORATION
- Product Code
- LKF
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MN
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 0
DURING THE SURGICAL PROCEDURE, THE LARGE V-CARE BALLOON WOULD NOT INFLATE. SURGERY WAS DELAYED WHILE A NEW ONE WAS OBTAINED. THERE WAS NO HARM TO THE PATIENT. COMPANY REPRESENTATIVE WAS CONTACTED REGARDING EVENT ON SAME DAY.
Description of Event or Problem · 1
DURING THE SURGICAL PROCEDURE, THE LARGE V-CARE BALLOON WOULD NOT INFLATE. SURGERY WAS DELAYED WHILE A NEW ONE WAS OBTAINED. THERE WAS NO HARM TO THE PATIENT. COMPANY REPRESENTATIVE WAS CONTACTED REGARDING EVENT ON SAME DAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 181730 | VCARE PLUS UTERINE MANIPULATOR | CANNULA, MANIPULATOR/INJECTOR, UTERINE | LKF | CONMED CORPORATION | 60-6085-202A | 201907081 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |