MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2014-08-08 for OLYMPUS HF RSECTION ELECTRODE, LOOP A22206C manufactured by Olympus Winter And Ibe Gmbh.
[20068037]
Olympus received a medwatch report stating that the tip of three electrodes broke off during a case. There was no pt harm reported. Olympus followed up with the user facility via phone and in writing in an effort to obtain additional info regarding the reported event with no results.
Patient Sequence No: 1, Text Type: D, B5
[20384806]
The device referred to in this report has not been returned to olympus for eval. The exact cause of the reported event could not be conclusively determined at this time. Olympus will continue to work with the user facility to obtain more detailed info regarding this report, and if new info is received at a later time this report will be updated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2951238-2014-00297 |
| MDR Report Key | 4143607 |
| Report Source | 06,07 |
| Date Received | 2014-08-08 |
| Date of Report | 2014-07-21 |
| Date of Event | 2014-07-01 |
| Date Mfgr Received | 2014-07-21 |
| Date Added to Maude | 2014-10-14 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | NOEMI SCHAMBACH |
| Manufacturer Street | 2400 RINGWOOD AVE. |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4089355002 |
| Manufacturer G1 | OLYMPUS WINTER AND IBE GMBH |
| Manufacturer Street | KUEHNSTRASSE 61 |
| Manufacturer City | HAMBURG 22045 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 22045 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS HF RSECTION ELECTRODE, LOOP |
| Generic Name | RSECTION ELECTRODE |
| Product Code | FDC |
| Date Received | 2014-08-08 |
| Model Number | A22206C |
| Catalog Number | A22206C |
| Lot Number | 13319P02L001 |
| ID Number | NA |
| 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 AND IBE GMBH |
| Manufacturer Address | KUEHNSTRASSE 61 HAMBURG 22045 GM 22045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-08-08 |