FDA Adverse Event
Malfunction
Summary report: N
VCARE MEDIUM, VAGINAL-CERVICAL-AHLUWALIA'S-RETRACTOR ELEVATOR UTERINE MANIPULATO
MDR report key: 8456151
·
Received March 26, 2019
Report
- Report Number
- MW5085187
- Event Type
- Malfunction
- Date Received
- March 26, 2019
- Date of Event
- March 22, 2019
- Report Date
- March 22, 2019
- Manufacturer
- CONMED CORPORATION
- Product Code
- LKF
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- PA, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
WHILE ATTEMPTING TO UTILIZE THE CONMED CORPORATION VCARE MEDIUM VAGINAL-CERVICAL-AHLUWALIA'S-RETRACTOR ELEVATOR UTERINE MANIPULATOR ACCORDING TO MFR'S RECOMMENDATIONS, THE BLUE PORTIONS OF THE CATHETER WOULD NOT APPROXIMATE, THEREBY NOT TIGHTENING, AND NOT ALLOWING THE CATHETER TO BE UTILIZED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 243700 | VCARE MEDIUM, VAGINAL-CERVICAL-AHLUWALIA'S-RETRACTOR ELEVATOR UTERINE MANIPULATO | CANNULA, MANIPULATOR / INJECTOR , UTERINE | LKF | CONMED CORPORATION | 60-6085-201A | 201901281 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR |