MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-12-28 for VC10 PUMP, 115V VC-10 manufactured by Gyrus Acmi, Inc.
[96004859]
The device was not returned to olympus for evaluation. The exact cause of the reported event cannot be determine; however, based on the reported event user error cannot be ruled out as a contributory factor. The instruction manual provides the user several warnings to mitigate patient injury. ? Study this manual and other labeling thoroughly for safe handling and storage. Misuse of instruments can cause injury to the patient and could have an adverse effect on the procedure being performed. The sliding ring on the handle may be used to control the vacuum. If the cannula adheres to the uterine wall or becomes clogged, release the suction by moving the sliding ring from the closed position to the open position to decrease the vacuum prior to removal of the cannula. For foot pedal operation, confirm that the foot pedal is properly attached. Do not apply excessive force while using the cannulas and f-sets. Excessive pushing, bending, or pulling could result in injury to the patient and/or breakage of the device.?
Patient Sequence No: 1, Text Type: N, H10
[96004860]
The user facility informed olympus that during a suction dilation and evacuation (d&e procedure, the end user released the footswitch but the vc-10 suction did not stop and the pressure increased resulting in the patient sustaining blood loss. The patient was administered multiple blood transfusions. The intended procedure was completed with a similar device. The patient was admitted to the hospital. In addition, the user facility? S team lead reported that it is believed that the tubing to the suction was set up improperly and attributed to the reported event. The end user inspected the fluid overflow protection/safety trap collection system post procedure and found that both canisters were full of fluid & tissue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2017-00791 |
| MDR Report Key | 7153069 |
| Report Source | USER FACILITY |
| Date Received | 2017-12-28 |
| Date of Report | 2018-08-27 |
| Date of Event | 2017-12-07 |
| Date Mfgr Received | 2018-08-22 |
| Date Added to Maude | 2017-12-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CONNIE TUBERA |
| Manufacturer Street | 2400 RINGWOOD AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 408935-512 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VC10 PUMP, 115V |
| Generic Name | VC10 PUMP |
| Product Code | HHI |
| Date Received | 2017-12-28 |
| Model Number | VC-10 |
| Catalog Number | VC-10 |
| ID Number | UDI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ACMI, INC |
| Manufacturer Address | 136 TURNPIKE ROAD SOUTHBOROUGH MA 01772 US 01772 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2017-12-28 |