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 2018-07-12 for HF-RESECTION ELECTRODE, ROLLER, 24-28 FR A22251C manufactured by Olympus Winter & Ibe Gmbh.
[113863261]
The referenced device will not be returned to olympus for a physical evaluation as the user facility discarded the device following the procedure. The cause of the reported event cannot be conclusively determined at this time. However, details regarding the patient and procedure are still being investigated. If additional information becomes available or if the device is returned for evaluation, this report will be supplemented accordingly.
Patient Sequence No: 1, Text Type: N, H10
[113863262]
Olympus was informed that a patient sustained burn to the perineum during a hysteroscopic ablation procedure. However, it was further reported that the burn was noted after the procedure. No additional information has been reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2018-00403 |
| MDR Report Key | 7684129 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-07-12 |
| Date of Report | 2018-07-13 |
| Date of Event | 2018-06-22 |
| Date Mfgr Received | 2018-07-13 |
| Device Manufacturer Date | 2017-01-02 |
| Date Added to Maude | 2018-07-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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, ROLLER, 24-28 FR |
| Generic Name | HF RESECNTION ELECTRODE, ROLLER |
| Product Code | GCP |
| Date Received | 2018-07-12 |
| Model Number | A22251C |
| Lot Number | P1710004 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 1. Other | 2018-07-12 |