MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2018-05-04 for WORKING ELEMENT, ACTIVE WA22066A manufactured by Olympus Winter & Ibe Gmbh.
[107316205]
The suspect medical device has not yet been returned to olympus for evaluation/investigation. Therefore, the exact cause of the user's experience and the reported phenomenon could not be determined and is being judged as unknown. However, if the suspect medical device is returned for evaluation/investigation or additional significant information becomes available, this report will be updated.
Patient Sequence No: 1, Text Type: N, H10
[107316206]
Olympus was informed that during a therapeutic transurethral resection of the prostate (turp) procedure, the patient's bladder was perforated. The physician assumed that this perforation was caused by the working element. No further information was provided. However, there was no report of malfunction for any of the medical devices.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610773-2018-00041 |
| MDR Report Key | 7486042 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2018-05-04 |
| Date of Report | 2018-05-28 |
| Date of Event | 2018-04-16 |
| Date Mfgr Received | 2018-05-22 |
| Device Manufacturer Date | 2010-06-09 |
| Date Added to Maude | 2018-05-04 |
| 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 |
| Manufacturer G1 | OLYMPUS WINTER & IBE GMBH |
| Manufacturer Street | KUEHNSTRASSE 61 |
| Manufacturer City | HAMBURG |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WORKING ELEMENT, ACTIVE |
| Generic Name | WORKING ELEMENTS (MONOPOLAR, BIPOLAR, FOR KNIVES, FOR PROBES) |
| Product Code | GCP |
| Date Received | 2018-05-04 |
| Returned To Mfg | 2018-05-16 |
| Model Number | WA22066A |
| Catalog Number | WA22066A |
| Lot Number | 106W |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-05-04 |