MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-06-19 for BERKELEY VC VACUUM CURETTAGE SYSTEMS VC-2 manufactured by Gyrus Acmi, Inc..
[5847402]
Olympus received a voluntary medwatch which stated, "a patient was undergoing a dilation and curettage (d&c) in the operating room (or). The suction pump was only working intermittently and then the pump stopped working. An or nurse picked up the power cord to see if the device was plugged in. The machine turned back on and a humming noise was heard. The operating room nurse then grabbed the cord to pull out of the wall and the cord caught on fire. The nurse sustained a 2nd degree burn to her hand. The patient was not injured. " olympus followed up with the user facility via telephone and in writing to obtain additional information regarding the report but was unsuccessful.
Patient Sequence No: 1, Text Type: D, B5
[13375384]
The device referenced in this report has not yet been returned to olympus for evaluation. The exact cause of the reported event could not be conclusively determined at this time. If additional information or if the device is received at a later time, this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2951238-2015-00271 |
| MDR Report Key | 4857203 |
| Report Source | 05,06 |
| Date Received | 2015-06-19 |
| Date of Report | 2015-06-01 |
| Date of Event | 2015-01-09 |
| Date Mfgr Received | 2015-06-01 |
| Date Added to Maude | 2015-06-19 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MRS. NOEMI SCHAMBACH |
| Manufacturer Street | 2400 RINGWOOD AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4089355002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BERKELEY VC VACUUM CURETTAGE SYSTEMS |
| Generic Name | VACUUM CURETTAGE SYSTEMS |
| Product Code | HHI |
| Date Received | 2015-06-19 |
| Model Number | VC-2 |
| Catalog Number | VC-2 |
| Lot Number | N/A |
| 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 01772210 US 01772 2104 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-06-19 |