MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-12 for IGLESIAS WORKING ELEMENT EIWE manufactured by Gyrus Acmi, Inc.
[79918496]
The device was not returned to olympus for evaluation. The cause of the reported event cannot be determined.
Patient Sequence No: 1, Text Type: N, H10
[79918497]
Olympus was informed that during an unspecified procedure, the surgeon heard a sizzle sound and observed a flash / spark from the working element. The procedure was completed with a different device. There was no patient injury reported
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2017-00451 |
| MDR Report Key | 6706794 |
| Date Received | 2017-07-12 |
| Date of Report | 2017-08-18 |
| Date of Event | 2017-06-23 |
| Date Mfgr Received | 2017-08-07 |
| Date Added to Maude | 2017-07-12 |
| 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 | 0 |
| Brand Name | IGLESIAS WORKING ELEMENT |
| Generic Name | IGLESIAS WORKING ELEMENT |
| Product Code | FBO |
| Date Received | 2017-07-12 |
| Returned To Mfg | 2017-08-02 |
| Model Number | EIWE |
| Catalog Number | EIWE |
| Lot Number | UNKNOWN |
| ID Number | UDI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-07-12 |