MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-28 for PKG, MEDICAL POWER SUPPLY 0240031004 manufactured by Stryker Endoscopy-san Jose.
[23092806]
Additional information will be provided once the investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10
[23092807]
It has been reported by the technical services that the product is not working. There was a delay of 30-60 minutes.
Patient Sequence No: 1, Text Type: D, B5
[32347831]
The product was returned and the failure mode was confirmed. Visual inspection: no visual damage outside the pkg, medical power supply. Functional inspection : power supply not working was verified using a vision pro monitor. Probable root cause/s could be a bad power supply. 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
[32347832]
It has been reported by the technical services that the product is not working. Additional information: there was a delay of 30-60 minutes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002936485-2015-00683 |
| MDR Report Key | 4947943 |
| Date Received | 2015-07-28 |
| Date of Report | 2015-07-03 |
| Date of Event | 2015-06-30 |
| Date Mfgr Received | 2015-07-03 |
| Date Added to Maude | 2015-07-28 |
| 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 |
| 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 | 2015-07-28 |
| Returned To Mfg | 2015-07-30 |
| 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 | 2015-07-28 |