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.
[113631367]
The device was returned to olympus for evaluation. A visual inspection of the device found char marks inside the electrode insertion port of the white actuator block. The shaft of the device was critically bent and cracked at the proximal end damaging both the telescope and electrode channels which is indicative of user handling. In addition, there are scratches and a cold solder joint between the shaft and the nose cone. The exact cause of the reported event could not be conclusively determined as the concomitant devices were not returned along with the device for evaluation. However, based on the evaluation and similar reported events, the most probable cause of the reported event could be attributed to mis-assembly of electrode and activation cord or fluid/debris inside the actuator block that could have caused spark/arc discharge when the hf current was activated. The damage and the cold solder joint on device suggest that the device could have been repaired by a third party. 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
[113631368]
Olympus was informed that during a therapeutic procedure, the device sparked at the electrode connection point. The device and boston scientific electrode were replaced with different devices and the intended procedure was completed. No patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2018-00398 |
| MDR Report Key | 7667956 |
| Date Received | 2018-07-06 |
| Date of Report | 2018-07-06 |
| Date Mfgr Received | 2018-06-19 |
| 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 | 2018-06-13 |
| Model Number | EIWE |
| Catalog Number | EIWE |
| Lot Number | IC |
| Device Availability | R |
| 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 |