MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-02-24 for PK FRONT LOAD,IGLESIAS,WORKING ELEMENT EIWE-PKFL manufactured by Gyrus Acmi, Inc.
[139849456]
The customer returned the working element and the superloop electrode with no hf cable. A visual inspection of the working element was performed; non-olympus markings engraved on the working element, consistent that the device may have been repaired by an unauthorized third party. The working element block actuator was burned and charred. In addition, the connector side of the electrode and hf cable are burned and damaged. Charring was also observed on the electrodes proximal ends. A water leak test was performed on the working element and it failed the leak test between seal and handle. The most likely cause of the reported complaint is due to a bad seal within the handle of the working element. Which can cause water leak through the handle onto the block actuator and can lead to electrical shorting.
Patient Sequence No: 1, Text Type: N, H10
[139849477]
Olympus was informed that at the beginning of a transurethral resection of a bladder tumor, the doctor pressed the pedal to cut and the device sparked at the area where the loop electrode, and its cable are connected. Smoke was minimal so no evacuation of the operating room was needed. The intended procedure was completed with a button electrode. There was no patient or user injury reported. The super loop electrode and connections were inspected; no anomalies were observed. There were no errors displayed on the generator.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2019-00451 |
| MDR Report Key | 8364682 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-02-24 |
| Date of Report | 2019-03-18 |
| Date of Event | 2019-01-28 |
| Date Mfgr Received | 2019-02-28 |
| Date Added to Maude | 2019-02-24 |
| 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 | 3 |
| Brand Name | PK FRONT LOAD,IGLESIAS,WORKING ELEMENT |
| Generic Name | IGLESIAS WORKING ELEMEN |
| Product Code | FBO |
| Date Received | 2019-02-24 |
| Returned To Mfg | 2019-02-12 |
| Model Number | EIWE-PKFL |
| Lot Number | DO |
| 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 | 2019-02-24 |