MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-03-08 for CYSTO-NEPHRO VIDEOSCOPE CYF-VHR manufactured by Olympus Medical Systems Corp..
[138257415]
The scope was returned to olympus for evaluation. A visual inspection was performed on the received condition of the scope and found the bending section cover blown/torn apart; the bending section mesh was exposed. There was no damage noted on the distal end cover. In addition, one of the light guide lens has scratches and a chipped mark from the distal tip. As a result, no leak test could be performed. A review of the scope? S instrument history shows the scope was purchased on (b)(6) 2015 and was last serviced on (b)(6) 2018. The cause of the reported event could not be conclusively determined. However, based on similar reported complaints, the most probable cause of a blown bending section cover can be attributed to improper handling. To mitigate the risk of damage to the scope, the instruction manual provides the do not strike, hit, or drop the endoscope? S distal end, insertion tube, bending section, control section, universal cord, video connector, or light guide connector. Also, do not bend, pull, or twist the endoscope? S distal end, insertion tube, bending section, control section, universal cord, video connector, or light guide connector with excessive force. The endoscope may be damaged and could cause patient injury, burns, bleeding, and/or perforations. It could also cause parts of the endoscope to fall off inside the patient. As part of our investigation, olympus followed up with the user facility via telephone and in writing to obtain additional information regarding the reported complaint but no information was obtained. Accordingly. However, if additional information is received this report will be supplemented
Patient Sequence No: 1, Text Type: N, H10
[138257416]
Olympus was informed that during a therapeutic procedure, the scope? S tip broke. There was no patient injury reported. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2019-00523 |
| MDR Report Key | 8404051 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-03-08 |
| Date of Report | 2019-03-08 |
| Date Mfgr Received | 2019-02-08 |
| Date Added to Maude | 2019-03-08 |
| 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 | CYSTO-NEPHRO VIDEOSCOPE |
| Generic Name | CYSTO-NEPHRO VIDEOSCOPE |
| Product Code | NWB |
| Date Received | 2019-03-08 |
| Returned To Mfg | 2019-02-12 |
| Model Number | CYF-VHR |
| 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 | 2019-03-08 |