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 2018-02-08 for CYSTO-NEPHRO VIDEOSCOPE CYF-VHR manufactured by Olympus Medical Systems Corp..
[99937620]
The scope was returned to olympus for evaluation. A visual inspection of the device found the bending section cover glue/cement at the distal end side of the insertion tube is cracked, chipped and partially missing exposing the bending section assembly threading. In addition, there is a kink/indentation on the bending section next to the damaged bending section cover glue/cement. The scope passed the leak test. A repair/replacement scope was sent to the user facility. The cause of the reported event could not be conclusively determined, however, based on the evaluation results the damaged glue/cement and kink on the bending section are indicative of user handling. 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
[99937621]
Olympus was informed that during a cystoscopy procedure, parts of the scope around the bending section are flaking off inside the patient? S bladder. The device fragments were removed from the patient. No patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2018-00089 |
| MDR Report Key | 7252055 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-02-08 |
| Date of Report | 2019-03-01 |
| Date of Event | 2018-01-18 |
| Date Mfgr Received | 2019-02-13 |
| Date Added to Maude | 2018-02-08 |
| 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 | 408935-512 |
| 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 | 2018-02-08 |
| Returned To Mfg | 2018-01-24 |
| Model Number | CYF-VHR |
| Catalog Number | CYF-VHR |
| Lot Number | N/A |
| ID Number | 04953170310522 |
| Operator | PHYSICIAN |
| 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 | 2018-02-08 |