MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-21 for HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35 A22205C manufactured by Olympus Winter & Ibe Gmbh.
[131772804]
The device was not returned to olympus for evaluation. The exact cause of the reported event could not be confirmed, however, based on similar reported complaints the reported event can occur from mechanical overload by the application of excessive force and or the electrode comes into contact (unintended) with other metal parts, e. G. Surgical instruments while the high-frequency output was activated. If the device is returned at a later date, this report will be supplemented accordingly.
Patient Sequence No: 1, Text Type: N, H10
[131772805]
Olympus was informed that during a transurethral resection of a prostate (turp) procedure, the loop wire at the distal end of the device broke off and fell into the patient? S bladder. The device was retrieved from the patient. There was no delay in the procedure as the intended procedure was completed using a second device from the same lot. In addition, there was no sparking or arcing observed during procedure; there was no unexpected bleeding to the patient; there was no issue withdrawing the device from the patient and the patient did not require additional procedures or treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2018-00801 |
| MDR Report Key | 8192363 |
| Date Received | 2018-12-21 |
| Date of Report | 2019-02-14 |
| Date of Event | 2018-12-05 |
| Date Mfgr Received | 2019-02-12 |
| Date Added to Maude | 2018-12-21 |
| 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 | HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35 |
| Generic Name | HF ELECTRODE, LOOP |
| Product Code | GCP |
| Date Received | 2018-12-21 |
| Model Number | A22205C |
| Lot Number | 1000024185 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-12-21 |