MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-16 for CONMED/LINVATEC PRO5200M manufactured by Linvatec.
[55581553]
Surgeon was using the powerpro max the handpiece started getting hot was smoking. The handpiece was removed from the field and the pt was check for injury. No injuries were noted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5973890 |
| MDR Report Key | 5973890 |
| Date Received | 2016-09-16 |
| Date of Report | 2016-09-16 |
| Date of Event | 2016-09-15 |
| Date Facility Aware | 2016-09-15 |
| Report Date | 2016-09-16 |
| Date Reported to FDA | 2016-09-16 |
| Date Added to Maude | 2016-09-23 |
| 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 | 0 |
| Brand Name | CONMED/LINVATEC |
| Generic Name | HALL POWERPRO MAX REF PRO5200M/BBC11712 |
| Product Code | HAM |
| Date Received | 2016-09-16 |
| Model Number | PRO5200M |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 11 YR |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LINVATEC |
| Manufacturer Address | 11155 CONCEPT BLVD LARGO FL 33773 US 33773 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-09-16 |