MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-01 for VISERA ELITE VIDEO SYSTEM CENTER OTV-S190 manufactured by Olympus Medical Systems Corp..
[113283163]
The subject otv-s190 was returned to olympus medical systems corp. (omsc). The subject otv-s190 and ch-s190-08-lb (omsc asset) were connected to check the operation of the subject otv-s190. As a result, the reported malfunction was not reproduced. The investigation of the subject otv-s190 confirmed the following details: no abnormality was found in the subject otv-s190 when it was operated in the system stated above. The cycle of ("the scope was connected to the otv-s190", "the otv-s190 was turning on ", "displayed error was checked", "the otv-s190 was turning off", "the scope was disconnected to the otv-s190") was repeated 50 times. The chassis of the otv-s190 was vibrated repeatedly 30 times. Power was continuously supplied to the system including the subject otv-s190 for 1 hour. The cycle of ("the scope was connected to the otv-s190", "the otv-s190 was turning on ", "displayed error was checked", "the otv-s190 was turning off", "the scope was disconnected to the otv-s190") was repeated 50 times. The chassis of the otv-s190 was vibrated repeatedly 30 times. The otv-s190 was observed in appearance, but there were no abnormalities such as dirt, foreign matter, scratches, distortion and the like. When observing the inside of the scope connector of otv - s190, there was no abnormality such as foreign objects adhering. Error codes "e216" and "b30" are described in the instruction manual of the otv-s190 as scope communication errors that occur when foreign objects are attached to the electrical contacts of the scope connector section. Omsc performed an investigation on the actual otv-s190. The reported phenomenon was not reproduced. The root cause of this phenomenon could not be conclusively determined. There is a possibility that temporary foreign objects are attached to the electrical contacts of the scope connector section, resulting malfunction of the scope communication errors.
Patient Sequence No: 1, Text Type: N, H10
[113283164]
During an unspecified procedure of urology using the otv-s190, sandstorm - like noise was generated in the endoscopic image. When the user disconnected the camera head from the otv-s190 and connected again, the error code "e216", "b30" was displayed on the monitor. When replaced with another camera head similar to the camera head, the appearance of the monitor display did not change and the malfunction was not resolved. The user replaced the endoscope system including the subject otv-s190 with another similar endoscope system and completed the procedure. There was no report of the patient? S injury regarding this event other than the replacement of the subject device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2018-01251 |
| MDR Report Key | 7654090 |
| Date Received | 2018-07-01 |
| Date of Report | 2018-07-02 |
| Date of Event | 2018-06-06 |
| Date Mfgr Received | 2018-06-06 |
| Device Manufacturer Date | 2018-03-13 |
| Date Added to Maude | 2018-07-01 |
| 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 | VISERA ELITE VIDEO SYSTEM CENTER |
| Generic Name | VIDEO SYSTEM CENTER |
| Product Code | FET |
| Date Received | 2018-07-01 |
| Returned To Mfg | 2018-06-13 |
| Model Number | OTV-S190 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-01 |