MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-04-14 for OLYMPUS TURIS manufactured by Olympus.
[5662450]
Olympus turis resectoscope for transurethral resection of bladder tumor. Tip of device came off inside pt's bladder and required removal of foreign body resulting in trauma to the urethra. Hospital involved will be contacted to obtain concomitant medical products and therapy dates. Hosp is (b)(6) hosp (b)(6). Dates of use: (b)(6) 2015. Used for turp and turbt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5042134 |
| MDR Report Key | 4707027 |
| Date Received | 2015-04-14 |
| Date of Report | 2015-04-14 |
| Date of Event | 2015-07-13 |
| Date Added to Maude | 2015-04-21 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS TURIS |
| Generic Name | OLYMPUS TURIS |
| Product Code | FDC |
| Date Received | 2015-04-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS |
| Manufacturer Address | HAMBURG 237765 GM 237765 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-04-14 |