MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-06 for IGLESIAS WORKING ELEMENT EIWE manufactured by Gyrus Acmi, Inc.
[113643130]
The working element was not returned to olympus for evaluation. The cause of the reported event could not be determined at this time. However, based on similar reported events the most probable cause can be attributed to the debris or fluid inside the actuation block of the working element or the corresponding electrode is not connected properly inside the actuation block which can cause arcing. If the device is returned for evaluation at a later date, this report will be supplemented accordingly. The instruction manual warns users? Introduce a new plasmakinetic supersect/loop device and the instrument cable into the sterile field. Insert the t-shaped connector on the instrument cable into the slot on the base of the white instrument mounting block. Ensure that the connector is fully seated within the block.? In addition, the oem has attributed this type of phenomenon to fluids invading the connection block causing an electrical short to occur due to the poor connection of the electrode, working element and cable.
Patient Sequence No: 1, Text Type: N, H10
[113643131]
Olympus was informed that during set-up of an endometrial ablation procedure, a big spark occurred when the doctor was connecting the active cord to the working element. The spark was observed at the connection of the two devices. Both devices were replaced and the intended procedure was completed with similar devices without issue. It is unknown if the generator was on or if the cable was connected to the generator during the spark. The working element was inspected prior to set-up with no anomalies as the single use active cord was brand new. Both devices are expected to be returned for evaluation. 1 of 2 devices.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2018-00396 |
| MDR Report Key | 7667836 |
| Date Received | 2018-07-06 |
| Date of Report | 2018-09-06 |
| Date of Event | 2018-05-24 |
| Date Mfgr Received | 2018-08-16 |
| Date Added to Maude | 2018-07-06 |
| 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 | 0 |
| Brand Name | IGLESIAS WORKING ELEMENT |
| Generic Name | WORKING ELEMENT |
| Product Code | FBO |
| Date Received | 2018-07-06 |
| Returned To Mfg | 2018-08-13 |
| Model Number | EIWE |
| Catalog Number | EIWE |
| Lot Number | 2254942 |
| 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 | 2018-07-06 |