MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-04 for PKG, MEDICAL POWER SUPPLY 0240031004 manufactured by Stryker Endoscopy-san Jose.
[35016820]
Additional information will be provided once the investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10
[35016821]
The customer, (b)(6), reported that the power to the stack blew during the case. The customer further reported that as the stack was plugged in there was a power surge that went through other parts of the theatre, affecting the anaesthetic machine, part of an arthroscopy stack and a computer which was also in theatre. The customer reported that there was smoke in the theatre and the fire brigade was called. The stack was taken out of service. A patient was under anaesthetic and had to be woken up. The case was abandoned.
Patient Sequence No: 1, Text Type: D, B5
[42801064]
(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 medical power supply was tested with a known working vision pro monitor and power cord. There was no power coming out of the medical power supply. The power supply fails to power up a monitor. Probable root cause/s can be attributed to a power supply failure possibly 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
[42801065]
The customer, (b)(6), director of clinical services, reported that the power to the stack blew during the case. The customer further reported that as the stack was plugged in there was a power surge that went through other parts of the theatre, affecting the anaesthetic machine, part of an arthroscopy stack and a computer which was also in theatre. The customer reported that there was smoke in the theatre and the fire brigade was called. The stack was taken out of service. A patient was under anaesthetic and had to be woken up. The case was abandoned.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002936485-2016-00010 |
| MDR Report Key | 5342414 |
| Date Received | 2016-01-04 |
| Date of Report | 2015-12-07 |
| Date of Event | 2015-12-07 |
| Date Mfgr Received | 2015-12-07 |
| Date Added to Maude | 2016-01-04 |
| 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 | 2016-01-04 |
| Returned To Mfg | 2015-12-31 |
| Catalog Number | 0240031004 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 1. Other | 2016-01-04 |