MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-11-20 for VC10 PUMP, 115V VC-10 manufactured by Gyrus Acmi, Inc.
[128026456]
The device was not returned to olympus for evaluation. The cause of reported event cannot be determined at this time. The vc-10 instruction manual warns users "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. " as part of or investigation, olympus followed up with the user facility regarding the reported event and limited information was provided. Olympus will continue to investigate this complaint to obtain more detailed information regarding the reported complaint. If additional information becomes available, this report will be updated and supplemented accordingly.
Patient Sequence No: 1, Text Type: N, H10
[128026457]
Olympus was informed that the user facility performed 21 dilation and curettage (d&c) procedures between (b)(6) 2017 to present. Of that, four patients developed intrauterine hematomas and presented to the emergency room for treatment. In addition, patient 1 and patient 2 experienced heavy bleeding, patient 3 experienced pain with cramping and patient 4 developed a hematometrium. All four patients were managed under outpatient care. This is 1 of 4 reports.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2018-00713 |
| MDR Report Key | 8091993 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-11-20 |
| Date of Report | 2018-11-20 |
| Date Mfgr Received | 2018-11-04 |
| Date Added to Maude | 2018-11-20 |
| 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 | 4089355124 |
| 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 | 2018-11-20 |
| Model Number | VC-10 |
| Catalog Number | VC-10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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. Required No Informationntervention | 2018-11-20 |