MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-24 for IGLESIAS WORKING ELEMENT EIWE manufactured by Gyrus Acmi, Inc.
[134362197]
The reference device was not returned to olympus for evaluation. The exact cause of the reported event cannot be determined. However, 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
[134362198]
Olympus was informed that during a transurethral resection of the prostate procedure, there was a spark and then smoke that occurred at the actuator block of the device when used with a non-olympus electrode (boston scientific). The monopolar resectoscope equipment was switched out to all gyrus pk sp bipolar resectoscope equipment and the intended procedure was completed. There was no patient harm reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2019-00391 |
| MDR Report Key | 8276708 |
| Date Received | 2019-01-24 |
| Date of Report | 2019-03-20 |
| Date of Event | 2019-01-16 |
| Date Mfgr Received | 2019-03-20 |
| Date Added to Maude | 2019-01-24 |
| 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 | K951972 |
| Product Code | FBO |
| Date Received | 2019-01-24 |
| Returned To Mfg | 2019-01-25 |
| Model Number | EIWE |
| Lot Number | UNKNOWN |
| 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 | 2019-01-24 |