MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-03-31 for DVI-D CABLE, 30FT 0240060845 manufactured by Stryker Endoscopy-san Jose.
[4229320]
It was reported that the cable, which slides inside the grove of the cart's arm, is bare. User is concerned that this could cause an electrical shock to the medical staff. It was further reported that one of the cables is kinked.
Patient Sequence No: 1, Text Type: D, B5
[4739448]
It was reported that the cable, which slides inside the grove of the cart's arm, is bare. User is concerned that this could cause an electrical shock to the medical staff. It was further reported that one of the cables is kinked.
Patient Sequence No: 1, Text Type: D, B5
[11763487]
Additional information will be provided once the investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10
[12313566]
The product was returned and the failure mode was confirmed. Visual inspection found the insulation chord was wrapped in tape. When the tape was removed, the insulation from the chord was severed open and the metal wire was exposed. Probable root cause/s could be damaged chord during set up. The product was returned for investigation and the reported failure mode was confirmed. The failure mode will be monitored for future reoccurrence.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0002936485-2014-00180 |
| MDR Report Key | 3715610 |
| Report Source | 05 |
| Date Received | 2014-03-31 |
| Date of Report | 2014-03-04 |
| Date of Event | 2014-03-04 |
| Date Mfgr Received | 2014-03-04 |
| Date Added to Maude | 2014-05-28 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. THOMAS SHAFER |
| 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 | DVI-D CABLE, 30FT |
| Generic Name | CAMERA, TELEVISION, SURGICAL, WITHOUT AUDIO |
| Product Code | FWB |
| Date Received | 2014-03-31 |
| Returned To Mfg | 2014-03-28 |
| Catalog Number | 0240060845 |
| Lot Number | UNKNOWN |
| Operator | OTHER |
| Device Availability | R |
| Device Age | DA |
| 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 | 2014-03-31 |