MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-07-21 for IGLESIAS WORKING ELEMENT EIWE manufactured by Gyrus Acmi, Inc.
[80694919]
The device was not returned to olympus for evaluation. The cause for the reported event cannot be determined at this time.
Patient Sequence No: 1, Text Type: N, H10
[80694920]
Olympus was informed that during a transurethral resection of the prostate (turp) procedure, the surgeon observing smoke and charring on the working element, while utilizing the resectoscope. It was reported that all the equipment was replaced and upon activation the surgeon observed arcing & smoke near the connection of the working element, active cord and electrode. The bleeding was as expected for this type of procedure. The intended procedure was completed. The procedure was prolonged by element 30 minutes. There was no patient injury. This report 1 of 3.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2017-00464 |
| MDR Report Key | 6730890 |
| Report Source | USER FACILITY |
| Date Received | 2017-07-21 |
| Date of Report | 2017-07-20 |
| Date of Event | 2017-06-29 |
| Date Mfgr Received | 2017-06-30 |
| Date Added to Maude | 2017-07-21 |
| 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 | IGLESIAS WORKING ELEMENT |
| Generic Name | IGLESIAS WORKING ELEMENT |
| Product Code | FBO |
| Date Received | 2017-07-21 |
| Model Number | EIWE |
| Catalog Number | EIWE |
| Lot Number | REXO |
| ID Number | UDI |
| 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 | 2017-07-21 |