MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-11-27 for VE HDTV INTERNATIONAL KIT 0240030960I manufactured by Stryker Endoscopy-san Jose.
[128460762]
Alleged failure: displayed color stripes. Confirmed failure: damaged cma, main board failure, scratched pp filter. Probable root cause: scaler/descaler board. Power supply. Ac inlet board. Connectors. Firmware. Switch board. Use error. The product was returned for investigation and the failure mode will be monitored for future reoccurrence. The device manufacture date is not known.
Patient Sequence No: 1, Text Type: N, H10
[128460763]
It was reported that stripe colors were displayed on the monitor, which resulted to conversion to open surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002936485-2018-00704 |
| MDR Report Key | 8107437 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-11-27 |
| Date of Report | 2018-11-27 |
| Date of Event | 2018-07-07 |
| Date Mfgr Received | 2018-11-01 |
| Date Added to Maude | 2018-11-27 |
| 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. MICHELLE TO |
| 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 | 3 |
| Brand Name | VE HDTV INTERNATIONAL KIT |
| Generic Name | CAMERA, TELEVISION, SURGICAL, WITHOUT AUDIO |
| Product Code | FWB |
| Date Received | 2018-11-27 |
| Returned To Mfg | 2018-10-26 |
| Catalog Number | 0240030960I |
| Lot Number | VEH263D0281 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 1. Other | 2018-11-27 |