MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-05-23 for HF-RESECTION ELECTRODE, LOOP, 24 FR. A22201C manufactured by Olympus Winter & Ibe Gmbh.
[146076755]
The suspect medical device has not been returned to the manufacturer for evaluation/investigation. A device history record (dhr) was performed and no non conformances were noted. The issues connected with cracking of tungsten wire electrodes are being further investigated. However, the exact cause of the user's experience and the reported phenomenon could not be determined at this time. If the suspect medical device is returned for evaluation/investigation and/or additional significant information becomes available, this report will be updated.
Patient Sequence No: 1, Text Type: N, H10
[146076756]
The service center was informed that during a transurethral resection of bladder tumor (turbt) procedure, while the surgeon was resecting tissue it was noted that the loop was no longer attached to the tip of the 24fr resection loop. The surgeon and staff searched for the piece of loop through the cystoscope, in the specimen, and in the suction screen. After an extensive search the surgeon and staff was still were unable to find the piece of loop. No x-ray was performed as the surgeon felt the loop fragment would not be visible do to the size. The operating room supervisor verified no x-ray was required post- procedure due to the size of the object. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2019-00872 |
| MDR Report Key | 8639049 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-05-23 |
| Date of Report | 2019-08-09 |
| Date of Event | 2019-04-22 |
| Date Mfgr Received | 2019-07-12 |
| Date Added to Maude | 2019-05-23 |
| 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 | 4089355124 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HF-RESECTION ELECTRODE, LOOP, 24 FR. |
| Generic Name | RESECTION ELECTRODE |
| Product Code | GCP |
| Date Received | 2019-05-23 |
| Returned To Mfg | 2019-05-14 |
| Model Number | A22201C |
| Catalog Number | A22201C |
| Lot Number | 16120P03L001 |
| Operator | HEALTH PROFESSIONAL |
| 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 22045 GM 22045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-23 |