MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-11 for PKG; 26IN VISION ELECT HDTV SURGICAL VIEWING MONITOR 0240030960 manufactured by Stryker Endoscopy-san Jose.
[45103219]
The product was not returned for investigation; therefore, the reported failure mode was not confirmed. The failure mode will be monitored for future reoccurrence. Alleged failure: loss of image. Probable root cause: scaler/descaler board, power supply, ac inlet board, connectors, firmware, switch board, available channel. Software not properly upgraded by flashmaster. Prescan incorrectly eliminates channels. Use error the device manufacture date is not known at this time. However, should it become available it will be provided in future reports.
Patient Sequence No: 1, Text Type: N, H10
[45103220]
It was reported that the view on the monitor became black.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002936485-2016-00451 |
| MDR Report Key | 5647494 |
| Date Received | 2016-05-11 |
| Date of Report | 2016-04-15 |
| Date of Event | 2016-04-15 |
| Date Mfgr Received | 2016-04-15 |
| Date Added to Maude | 2016-05-11 |
| 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. KIMBERLY LYNCH |
| Manufacturer Street | 5900 OPTICAL COURT |
| Manufacturer City | SAN JOSE CA 95138 |
| Manufacturer Country | US |
| Manufacturer Postal | 95138 |
| Manufacturer Phone | 4087542000 |
| Manufacturer G1 | STRYKER ENDOSCOPY-SAN JOSE |
| Manufacturer Street | 5900 OPTICAL COURT |
| Manufacturer City | SAN JOSE CA 95138 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95138 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PKG; 26IN VISION ELECT HDTV SURGICAL VIEWING MONITOR |
| Generic Name | CAMERA, TELEVISION, SURGICAL, WITHOUT AUDIO |
| Product Code | FWB |
| Date Received | 2016-05-11 |
| Catalog Number | 0240030960 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER ENDOSCOPY-SAN JOSE |
| Manufacturer Address | 5900 OPTICAL COURT SAN JOSE CA 95138 US 95138 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-11 |