MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-04 for CYSTO-NEPHRO VIDEOSCOPE CYF-VHR manufactured by Olympus Medical Systems Corp..
[123201997]
The device was returned to olympus for evaluation. A visual inspection was performed on the returned device and the bending section cover glue from the distal end and insertion tube side cracked with portions of the cement missing/broken off. The missing/broken off cement was not returned. There were scratches noted on the bending section cover glue, which likely cause the damage to the cement. The scope? S biopsy channel was inspected with olympus telescope and no missing parts or foreign objects/materials were noted inside the channel. Based on the reported complaint the cause of the damage on the bending section cover cement is due to mishandling the instruction manual provides warning which states,? 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.?
Patient Sequence No: 1, Text Type: N, H10
[123201998]
Olympus was informed that during an unspecified procedure, a piece of the scope? S distal tip fell inside the patient's bladder. It is unknown if the device fragment was retrieved or if the intended procedure was completed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2018-00607 |
| MDR Report Key | 7937063 |
| Date Received | 2018-10-04 |
| Date of Report | 2019-03-01 |
| Date Mfgr Received | 2019-02-13 |
| Date Added to Maude | 2018-10-04 |
| 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 | 0 |
| Brand Name | CYSTO-NEPHRO VIDEOSCOPE |
| Generic Name | CYSTO-NEPHRO VIDEOSCOPE |
| Product Code | NWB |
| Date Received | 2018-10-04 |
| Returned To Mfg | 2018-09-27 |
| Model Number | CYF-VHR |
| Catalog Number | CYF-VHR |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 | 2018-10-04 |