MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-03-11 for OLYMPUS OES-PRO TELESCOPE A22002A manufactured by Olympus Winter & Ibe Gmbh.
[3193389]
Olympus was informed that during a button transurethral resection of the prostate (turp) surgery, a pt allegedly suffered a bladder perforation and died the next day.
Patient Sequence No: 1, Text Type: D, B5
[10630365]
Olympus followed up with the user facility via telephone and in writing but with no result. Olympus followed up with the reporter to obtain more info and was informed that during the procedure, the user had used a pressure machine with the bipolar button turp procedure. The reporter further stated that the user facility did not suspect the olympus equipment to be the cause of the pt's outcome. The subject device and associated olympus devices were not returned to olympus for eval. The exact cause of the pt outcome remains unk. This report will be supplemented if additional and significant info becomes available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610773-2013-00025 |
| MDR Report Key | 3008724 |
| Report Source | 06 |
| Date Received | 2013-03-11 |
| Date of Report | 2013-02-12 |
| Date Mfgr Received | 2013-02-12 |
| Date Added to Maude | 2013-03-19 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | LAURA STORMS-TYLER |
| Manufacturer Street | 2400 RINGWOOD AVE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4848965688 |
| Manufacturer G1 | OLYMPUS WINTER & 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 OES-PRO TELESCOPE |
| Generic Name | TELESCOPE |
| Product Code | FBP |
| Date Received | 2013-03-11 |
| Model Number | A22002A |
| Catalog Number | A22002A |
| Lot Number | NA |
| 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 & IBE GMBH |
| Manufacturer Address | KUEHNSTRASSE 61 HAMBURG 22045 GM 22045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2013-03-11 |