MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-01-23 for HF-RESECTION ELECTRODE, ROLLER A22251C manufactured by Olympus Winter & Ibe Gmbh.
[98287248]
The electrode 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 complaints the most probable cause of the reported event can occur from mechanical overload by the application of excessive force and improper handling, the electrode comes into contact (unintended) with other metal parts, e. G. Surgical instruments while the high-frequency output was activated and or higher output settings on the electrosurgical generator. The original equipment manufacturer (oem) conducted a review of the device history records (dhr) for the concerned lot number and found no deviations or non-conformities during the manufacturing process. If the electrode is returned to olympus for evaluation at a later date, this report will be supplemented accordingly.
Patient Sequence No: 1, Text Type: N, H10
[98287249]
Olympus received a voluntary medwatch (#mw5074270) that states during a transurethral resection of a prostate (turp) procedure, the roller ball of the electrode broke off inside the patient. A second electrode from the same lot was used and malfunctioned. The user facility informed olympus that the ball and other debris from the first electrode ended up in the patient's bladder. The second electrode burnt up and the distal end fell apart as well, but no device fragment fell inside the patient. The user switched to a loop electrode, and was able to complete the procedure. There was no patient injury reported. The staff was uncertain if the parts were successfully extracted from the patient, however, a post operative x-ray was performed on the patient the same day which showed no evidence of a foreign body. The patient was discharged in good condition. In addition, no bleeding to the patient occurred as a result. There was no sparking/arcing observed during procedure. The electrode was inspected prior to procedure with no obvious anomalies noted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2018-00036 |
| MDR Report Key | 7213294 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-01-23 |
| Date of Report | 2018-02-13 |
| Date of Event | 2017-12-18 |
| Date Mfgr Received | 2018-01-25 |
| Device Manufacturer Date | 2017-03-27 |
| Date Added to Maude | 2018-01-23 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | HF-RESECTION ELECTRODE, ROLLER |
| Generic Name | HF ELECTRODE |
| Product Code | GCP |
| Date Received | 2018-01-23 |
| Returned To Mfg | 2018-01-22 |
| Model Number | A22251C |
| Catalog Number | A22251C |
| Lot Number | P1730003 |
| ID Number | 14042761036815 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS WINTER & IBE GMBH |
| Manufacturer Address | KUEHNSTRASSE 61 HAMBURG, HAMBURG US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-23 |