MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-27 for PKG, MEDICAL POWER SUPPLY 0240031004 manufactured by Stryker Endoscopy-san Jose.
[51264120]
Additional information will be provided once the investigation has been completed. The device manufacture date is not known at this time. However, should it become available it will be provided in future reports. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[51264121]
It was reported that the power supply did not work properly during surgery causing a delay of 45 minutes. The procedure was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
[58044271]
The product was returned for investigation and the reported failure mode was confirmed. The failures identified in the investigation is consistent with the complaint record. Probable root cause/s can be attributed to a power supply failure possibly due to a bad component inside the power brick. The reported failure mode will be monitored for future reoccurrence. Mfg date: 03/01/2015. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[58044272]
It was reported that the power supply did not work properly during surgery causing a delay of 45 minutes. The procedure was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002936485-2016-00700 |
| MDR Report Key | 5826188 |
| Date Received | 2016-07-27 |
| Date of Report | 2016-06-30 |
| Date of Event | 2016-06-30 |
| Date Mfgr Received | 2016-06-30 |
| Device Manufacturer Date | 2015-03-01 |
| Date Added to Maude | 2016-07-27 |
| 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. 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 | 2016-07-27 |
| Returned To Mfg | 2016-07-28 |
| 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 | 2016-07-27 |