MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-02-08 for VISERA CYSTO-NEPHRO VIDEOSCOPE CYF-V2 manufactured by Olympus Medical Systems Corp..
[135678199]
As part of our investigation, multiple follow up attempts were made via telephone and in writing to contact the user facility to obtain addition information regarding the patient, procedure and scope but no information has been obtained to date. The scope was returned to olympus but the evaluation is in progress. Olympus will continue to investigate the reported event. If additional information becomes available, this report will be updated accordingly.
Patient Sequence No: 1, Text Type: N, H10
[135678200]
Olympus was informed that during a procedure, a scope became stuck inside the patient? S urethra. The scope? S insertion tube was in a 360 degree loop and the up lever worked but the down lever did not move the bending section tip of the scope. The physician had decided to cut the scope? S insertion tube and had to rush the patient into surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2019-00429 |
| MDR Report Key | 8324293 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-02-08 |
| Date of Report | 2019-03-11 |
| Date of Event | 2019-01-17 |
| Date Mfgr Received | 2019-02-12 |
| Device Manufacturer Date | 2014-10-20 |
| Date Added to Maude | 2019-02-08 |
| 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 | 2019-02-08 |
| Returned To Mfg | 2019-01-23 |
| Model Number | CYF-V2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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. Required No Informationntervention | 2019-02-08 |