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 2019-12-13 for HF-RESECTION ELECTRODE PLASMALOOP ? MEDIUM WA47506S manufactured by Olympus Winter & Ibe Gmbh.
[176954421]
The referenced hf resection electrode was not returned for evaluation. A review of the device history records (dhr) was conducted by the oem (oste); as a manufacturing and quality control review was performed for the affected lot without showing any non-conformities or deviations. The cause of the reported event could not be determined. However, if additional information becomes available or if the device is returned at a later date, this report will be supplemented accordingly.
Patient Sequence No: 1, Text Type: N, H10
[176954422]
The manufacturer was informed that during a hysteroscopic myomectomy procedure, the physician at the user facility noted the resection loop at the distal end of the hf-resection electrode "bent up, bent down, at one point seemed to combust and flash was seen". When the hf-resection electrode was retracted the loop was reportedly separated and the two insulated shafts at the distal end were stuck together. The loop at the distal end came off the end of two electrodes. The loop was retrieved from the patient. The resection of a seven centimeter submucosal fibroid was completed using another electrode. This report is for 1 of 2 electrode loops that broke off in the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610773-2019-00173 |
| MDR Report Key | 9467055 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-12-13 |
| Date of Report | 2020-03-04 |
| Date of Event | 2019-08-19 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2019-01-30 |
| Date Added to Maude | 2019-12-13 |
| 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 | MR. DANIEL WLADOW |
| Manufacturer Street | KUEHNSTRASSE 61 |
| Manufacturer City | HAMBURG 22045 |
| Manufacturer Country | GM |
| Manufacturer Postal | 22045 |
| Manufacturer Phone | 4940669662 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HF-RESECTION ELECTRODE PLASMALOOP ? MEDIUM |
| Generic Name | HF RESECTION ELECTRODE |
| Product Code | JOS |
| Date Received | 2019-12-13 |
| Returned To Mfg | 2020-01-14 |
| Model Number | WA47506S |
| Catalog Number | WA47506S |
| Lot Number | 1000035472 |
| 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 | 2019-12-13 |