MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-16 for RFB MDU HAND CNTRL PWRMX EL 72200616F manufactured by Smith & Nephew, Inc..
[183529860]
It was reported that smoke came out of the motor drive unit's cable when it was connected to the dii controller. The incident occurred before the procedure; therefore, there was no patient involvement. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1643264-2020-00138 |
| MDR Report Key | 9835668 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-16 |
| Date of Report | 2020-03-16 |
| Date of Event | 2020-02-24 |
| Date Mfgr Received | 2020-02-24 |
| Date Added to Maude | 2020-03-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | HOLLY TOPPING |
| Manufacturer Street | 7000 WEST WILLIAM CANNON DRIVE |
| Manufacturer City | AUSTIN TX 78735 |
| Manufacturer Country | US |
| Manufacturer Postal | 78735 |
| Manufacturer Phone | 5123913905 |
| Manufacturer G1 | SMITH & NEPHEW, INC. |
| Manufacturer Street | 76 S. MERIDIAN AVE. |
| Manufacturer City | OKLAHOMA CITY OK 731076512 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 731076512 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RFB MDU HAND CNTRL PWRMX EL |
| Generic Name | SAW, POWERED, AND ACCESSORIES |
| Product Code | HAB |
| Date Received | 2020-03-16 |
| Returned To Mfg | 2020-03-09 |
| Model Number | 72200616F |
| Catalog Number | 72200616F |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW, INC. |
| Manufacturer Address | 76 S. MERIDIAN AVE. OKLAHOMA CITY OK 731076512 US 731076512 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-16 |