MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-11 for PKG, MEDICAL POWER SUPPLY 0240031004 manufactured by Stryker Endoscopy-san Jose.
[40388640]
The device manufacture date is not known at this time. However, should it become available it will be provided in future reports. Additional information will be provided once the investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10
[40388641]
It was reported the monitor stopped working during laparoscope procedure and that he power supply was no longer supplying power to the monitor. The customer expressed concern and there were no adverse consequences to the patient.
Patient Sequence No: 1, Text Type: D, B5
[45717250]
(b)(4). The product was returned and the failure mode was confirmed. Visual inspection: no visible damage to the connector pins, wires and power brick. Functional inspection : the pkg, medical power supply was tested with a known working vision pro monitor and power chord. There was no power coming out of the pkg, medical power supply. Probable root cause/s could be a bad power supply due to a bad component inside the power brick. 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
[45717251]
It was reported the monitor stopped working during laparoscope procedure and that he power supply was no longer supplying power to the monitor. The customer expressed concern and there were no adverse consequences to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002936485-2016-00256 |
| MDR Report Key | 5496140 |
| Date Received | 2016-03-11 |
| Date of Report | 2016-02-15 |
| Date of Event | 2016-02-13 |
| Date Mfgr Received | 2016-02-15 |
| Date Added to Maude | 2016-03-11 |
| 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 | 3 |
| Brand Name | PKG, MEDICAL POWER SUPPLY |
| Generic Name | CAMERA, TELEVISION, SURGICAL, WITHOUT AUDIO |
| Product Code | FWB |
| Date Received | 2016-03-11 |
| Returned To Mfg | 2016-03-07 |
| Catalog Number | 0240031004 |
| 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 | 2016-03-11 |