MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-11-15 for IGLESIAS WORKING ELEMENT EIWE manufactured by Gyrus Acmi, Inc.
[92156271]
The device was returned to olympus and is currently pending evaluation. Olympus is still investigating this reported event and has followed up with the user facility via telephone and in writing to obtain additional information. The exact cause for the reported event cannot be determined at this time.
Patient Sequence No: 1, Text Type: N, H10
[92156272]
Olympus was informed that during an unspecified procedure, the surgeon sustained a burn to the hand, while operating the working element. The surgeon inspected the inside of the working element and noted black char where it had burnt. It is unknown if the intended procedure was completed or if the surgeon was medically treated for the burn. There was no patient injury reported
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2017-00725 |
| MDR Report Key | 7033895 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-11-15 |
| Date of Report | 2018-01-19 |
| Date Mfgr Received | 2018-01-02 |
| Date Added to Maude | 2017-11-15 |
| 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 | 2017-11-15 |
| Returned To Mfg | 2017-12-27 |
| Model Number | EIWE |
| Catalog Number | EIWE |
| Lot Number | BP |
| 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 | 1. Other | 2017-11-15 |