MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-12-03 for CHOLEDOCHO VIDEOSCOPE CHF-V manufactured by Olympus Medical Systems Corp..
[93734211]
The subject device was returned to olympus medical systems corp. (omsc) for evaluation. In the evaluation, omsc confirmed the endoscopic image disappeared when the bending section was angulated. The insertion tube of the subject device was crushed due to physical damage. Omsc reviewed the manufacturing history of the subject device and confirmed no irregularity. The subject device has no repair history for approximately six years. The cause of the reported event could not be conclusively determined. However, the possible cause of the reported event might be aging deterioration or the broken electrical components within the insertion tube. The electrical components possibly broke due to physical damage which was applied when the insertion tube was crushed. The operation manual has already warned;? Do not bend, hit or twist the insertion section, control section, universal cord and video connector. The endoscope may be damaged and water leaks and/or breakage of internal parts like the ccd cable can result.? If additional information is received, this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10
[93734212]
Olympus was informed that the endoscopic image of the subject device was disappeared during an unspecified therapeutic procedure. Since the event occurred at the end of the procedure, the facility completed the procedure without replacing the subject device. There was no report of patient injury associated with this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2017-01901 |
| MDR Report Key | 7078194 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-12-03 |
| Date of Report | 2017-12-04 |
| Date of Event | 2017-11-02 |
| Date Mfgr Received | 2017-11-06 |
| Device Manufacturer Date | 2011-11-21 |
| Date Added to Maude | 2017-12-03 |
| 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 KATSUAKI MORITA |
| 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 | 3 |
| Brand Name | CHOLEDOCHO VIDEOSCOPE |
| Generic Name | CHOLEDOCO VIDEOSCOPE |
| Product Code | FBO |
| Date Received | 2017-12-03 |
| Returned To Mfg | 2017-11-14 |
| Model Number | CHF-V |
| 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 | 2017-12-03 |