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 2020-03-26 for HF-RESECTION ELECTRODE, LOOP, 24 FR WA22306D manufactured by Olympus Winter & Ibe Gmbh.
[186560618]
The device was not returned to the service center for evaluation. Therefore, the exact cause of the user's experience and the reported phenomenon could not be determined. However, if the device is returned for evaluation or additional significant information becomes available, this report will be supplemented accordingly.
Patient Sequence No: 1, Text Type: N, H10
[186560619]
Olympus was notified by a user facility that during a procedure, the distal loop of the device broke off inside the patient. The surgical team was unable to remove the loop fragment under fluoroscopy. It was reported that the procedure was for therapeutic purposes. It has not been determined at this time if there was any patient injury as the patient was still under anesthesia when the event occurred. No additional information has been provided at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610773-2020-00099 |
| MDR Report Key | 9885559 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-26 |
| Date of Report | 2020-04-02 |
| Date of Event | 2020-03-06 |
| Date Mfgr Received | 2020-03-27 |
| Date Added to Maude | 2020-03-26 |
| 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 | 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, LOOP, 24 FR |
| Generic Name | ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIES |
| Product Code | FAS |
| Date Received | 2020-03-26 |
| Model Number | WA22306D |
| Catalog Number | WA22306D |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 22045 GM 22045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-26 |