MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-23 for HAND HELD SAW OSCILLATOR SAW 100707 manufactured by Depuy Synthes.
[98228816]
First noted with this pt but we have had multiple issues related to residual moisture contamination in hand held saws subsequent to the sterilization cycle. The moisture leaks from under the top of the hand held saw.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5074763 |
| MDR Report Key | 7214906 |
| Date Received | 2018-01-23 |
| Date of Report | 2018-01-21 |
| Date of Event | 2017-12-12 |
| Date Added to Maude | 2018-01-24 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | HAND HELD SAW |
| Generic Name | HAND HELD SAW |
| Product Code | HSO |
| Date Received | 2018-01-23 |
| Returned To Mfg | 2017-12-20 |
| Model Number | OSCILLATOR SAW |
| Catalog Number | 100707 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY SYNTHES |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-23 |