MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-20 for 7208000000 manufactured by Stryker Endoscopy.
[70338399]
Patient Sequence No: 1, Text Type: N, H10
[70338400]
Stryker system saw 7 became very hot while the surgeon was using the device. A photo of the device with identifying numbers will be e-mailed. Event states no patient involved. No clinical outcome or consequences. Rep from stryker is aware of the issue and is sending a loaner. A new device was brought to the room and used to complete the case.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6416849 |
| MDR Report Key | 6416849 |
| Date Received | 2017-03-20 |
| Date of Report | 2017-03-08 |
| Date of Event | 2017-03-07 |
| Report Date | 2017-03-08 |
| Date Reported to FDA | 2017-03-08 |
| Date Reported to Mfgr | 2017-03-08 |
| Date Added to Maude | 2017-03-20 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NA |
| Generic Name | INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT |
| Product Code | DWI |
| Date Received | 2017-03-20 |
| Model Number | 7208000000 |
| Catalog Number | 7208000000 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER ENDOSCOPY |
| Manufacturer Address | 5900 OPTICAL CT. SAN JOSE CA 95138 US 95138 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-20 |