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 2019-01-31 for VISERA CYSTO-NEPHRO VIDEOSCOPE CYF-V2 manufactured by Olympus Medical Systems Corp..
[135523274]
The scope was returned to olympus for evaluation. The evaluation of the referenced scope found the bending section cover glue was cracked exposing the threading at the bending section which would indicate that a piece of the bending section cover glue was missing. The bending section cover, distal end plastic cover and insertion tube were intact. The scope did not pass the leak test due to the cracked bending section cover glue at the distal end. There were 385 usages with the device. A review of the scope? S instrument history record shows the scope was purchased in (b)(4) 2013 and was last repaired on april 20, 2017. The cause of the reported event could not be confirmed, however, the ifu? S troubleshoot section warns,? If any parts of the endoscope fall off inside the patient? S body due to equipment damage or failure, stop using the endoscope immediately and retrieve the parts in an appropriate way.? The instruction manual also provides warning and cautions which state? Do not strike, bend, hit, pull, twist, or drop the endoscope? S distal end, insertion tube, bending section, and control section with excessive force. The endoscope may be damaged and could cause patient injury, such as burns, bleeding, and/or perforation. It could also cause parts of the endoscope to fall off inside the patient.?
Patient Sequence No: 1, Text Type: N, H10
[135523275]
Olympus was informed that after performing a cystoscopy procedure, the doctor saw a small black fragment inside the patient? S bladder. The scope was then inspected and the doctor noticed a piece of the distal end cover was missing. The small black fragment in patient's bladder could not be retrieved by the staff as they attempted several times. The user facility reported that "because it is small in size the patient will eventually urinate it out. The procedure was completed as the black piece was only noted at the end of the procedure. There was no patient injury reported. In addition, the patient did not require a longer stay or additional treatment. The scope was inspected with no anomalies observed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2019-00393 |
| MDR Report Key | 8293453 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-01-31 |
| Date of Report | 2019-01-31 |
| Date of Event | 2018-12-31 |
| Date Mfgr Received | 2019-01-02 |
| Date Added to Maude | 2019-01-31 |
| 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 | 2019-01-31 |
| Returned To Mfg | 2019-01-02 |
| 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 | 2019-01-31 |