MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-16 for CHOLEDOCHO VIDEOSCOPE CHF-V manufactured by Olympus Medical Systems Corp..
[145392161]
The subject device has not been returned to omsc for evaluation, but olympus (b)(4) informed that there was a scratch at the distal end of the subject device. Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity. The exact cause could not be determined at present. If significant additional information is received, this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10
[145392162]
Olympus medical systems corp. (omsc) was informed that during an inspection ar the user facility before a transurethral lithotripsy procedure, the endoscopic image of the subject device was not displayed on the monitor and the user facility had to change the subject device with another but similar device. The user facility completed the procedure using the similar device and there was no report of patient injury associated with the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2019-01954 |
| MDR Report Key | 8614815 |
| Date Received | 2019-05-16 |
| Date of Report | 2019-05-16 |
| Date of Event | 2019-03-27 |
| Date Mfgr Received | 2019-04-18 |
| Device Manufacturer Date | 2015-03-11 |
| Date Added to Maude | 2019-05-16 |
| 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 | MR KAZUTAKA MATSUMOTO |
| Manufacturer Street | 2951 ISHIKAWA-CHO |
| Manufacturer City | HACHIOJI-SHI, TOKYO-TO 192-8507 |
| Manufacturer Country | JA |
| Manufacturer Postal | 192-8507 |
| Manufacturer Phone | 426425177 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CHOLEDOCHO VIDEOSCOPE |
| Generic Name | CHOLEDOCO VIDEOSCOPE |
| Product Code | FBN |
| Date Received | 2019-05-16 |
| Model Number | CHF-V |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-05-16 |