MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-04-29 for HF-RESECTION ELECTRODE, LOOP A22205C manufactured by Olympus Winter & Ibe Gmbh.
[143456934]
As part of our investigation, olympus followed-up with the user facility to obtain additional information. The user facility further reported that the loop at the distal end of the device broke off and fell into the patient? S prostatic urethra. The loop was retrieved and the device was removed from the patient without harm. In addition, the procedure was prolonged by 5 minutes. There was no sparking/arcing observed during procedure. There was no unexpected bleeding to the patient observed and the patient did not require a longer stay or additional treatment. Prior to procedure, the electrode was inspected with no irregularities noted. The generator settings were set to 200 cut, 80 coag; no error message was displayed. The oem conducted a review of the device history records (dhr) for the referenced device/lot number and there was no deviations or non-conformities noted during the manufacturing process. The referenced device will not be returned to olympus, therefore, the exact cause of the reported event cannot be confirmed. However, based on similar reported complaints, the reported event can potentially occur if the electrode comes into contact (unintended) with other metal parts, e. G. Surgical instruments while the high-frequency output was activated. As a preventive measure, the instruction manual contains several warning and caution statements in an effort to prevent damage to the electrode. Visually inspect the instrument prior to use. Warped electrodes, defective insulation and broken, cracked, or irregular cutting loops represent a danger for both the patient and the surgeon and must not be used. If the instrument is damaged or does not function properly, replace it.
Patient Sequence No: 1, Text Type: N, H10
[143456935]
Olympus was informed that during a transurethral resection of a prostate (turp) procedure, the loop at the distal end of the device appeared to be thinning out and the loop would break at the apex. The intended procedure was completed utilizing a second like device from the same lot. The reported event did not impact to the outcome of the procedure. No patient injury was reported. The reported device was discarded by the user facility following the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2019-00782 |
| MDR Report Key | 8561385 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-04-29 |
| Date of Report | 2019-04-29 |
| Date Mfgr Received | 2019-04-25 |
| Date Added to Maude | 2019-04-29 |
| 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 | HF-RESECTION ELECTRODE, LOOP |
| Generic Name | HF RESECTION ELECTRODE LOOP |
| Product Code | GCP |
| Date Received | 2019-04-29 |
| Model Number | A22205C |
| Catalog Number | A22205C |
| Lot Number | 1000032107 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 22045 GM 22045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-29 |