MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other report with the FDA on 2018-12-20 for VISERA CYSTO-NEPHRO VIDEOSCOPE UNKNOWN manufactured by Olympus Medical Systems Corp..
[131136607]
The legal document did not specify a model, serial or lot number for any of the devices that allegedly attributed to the patient? S outcome. Therefore, it is unknown if the device was returned to olympus for evaluation, service or repair. In addition, as part of our investigation olympus followed up with (b)(6) and was informed by the facility? S vice president of quality management that the facility does not use olympus equipment and therefore, cannot provide any details regarding the mentioned patient or procedure. Olympus will continue to investigate this complaint to obtain more detailed information regarding the reported events. If additional information becomes available, this report will be updated and supplemented accordingly.
Patient Sequence No: 1, Text Type: N, H10
[131136608]
On (b)(6) 2018, olympus received a legal document that alleges during a cystoscopy with urethral dilation and transurethral resection/ablation of prostate with bipolar procedure, a patient sustained a thermal injury to the bladder and urethra. According the legal document, the patient was under anesthesia when the alleged injury occurred. It is unknown if the patient was treated or if intended procedure was completed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2018-00784 |
| MDR Report Key | 8188042 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2018-12-20 |
| Date of Report | 2019-03-01 |
| Date of Event | 2016-11-30 |
| Date Mfgr Received | 2019-02-13 |
| Date Added to Maude | 2018-12-20 |
| 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 | 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 | VISERA CYSTO-NEPHRO VIDEOSCOPE |
| Generic Name | CYSTO-NEPHRO VIDEOSCOPE |
| Product Code | NWB |
| Date Received | 2018-12-20 |
| Model Number | UNKNOWN |
| Catalog Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORP. |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO-TO 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2018-12-20 |