MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-27 for PKG, MEDICAL POWER SUPPLY 0240031004 manufactured by Stryker Endoscopy-san Jose.
[58821149]
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
[58821150]
It was reported that the device broke down, which caused one additional hour of anesthesia for the patient. The procedure was completed successfully with replacement device.
Patient Sequence No: 1, Text Type: D, B5
[68472996]
Alleged failure: the product has broken down. The failure(s) identified in the investigation is consistent with the complaint record. The probable root cause/s could be (1) defective component inside the power brick (2) the power brick was opened and damages the component inside. The product was returned for investigation and the failure mode will be monitored for future reoccurrence. The device manufacturer date is not known. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[68472997]
It was reported that the device broke down, which caused one additional hour of anesthesia for the patient. The procedure was completed successfully with replacement device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002936485-2016-01012 |
| MDR Report Key | 6062470 |
| Date Received | 2016-10-27 |
| Date of Report | 2017-02-08 |
| Date of Event | 2016-09-30 |
| Date Mfgr Received | 2016-09-30 |
| Date Added to Maude | 2016-10-27 |
| 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 | 2016-10-27 |
| Returned To Mfg | 2016-11-02 |
| 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 | 2016-10-27 |