MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-12 for DEMAYO KNEE POSITINER #803 manufactured by Innovative Medical Products, Inc..
[180122587]
Per spd- while working in central sterilization processing yesterday, i was preparing the demayo knee positioner for packaging into it? S sterilization case. While handling the green anodized boot portion, i felt an oily residue on the posterior segment, near welded fin bracket. Upon closer examination it was found that there is a gap between the boot and the tack welded fin support. The gap extends the length of the finned rib. I noticed that the imp literature for sterilization does not address the issue, and wanted to bring it to your attention. I attempted to decontaminate the boot further by using high pressure water and enzymatic solution. In doing so, it appears older built-up bioburden was removed, however it remains impossible to access for proper cleaning. It is inaccessible to brush or examine with a scope. This device was demyao knee positioner #803. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092979 |
| MDR Report Key | 9706489 |
| Date Received | 2020-02-12 |
| Date of Report | 2020-02-10 |
| Date of Event | 2020-01-29 |
| Date Added to Maude | 2020-02-13 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | DEMAYO KNEE POSITINER |
| Generic Name | OPERATING ROOM ACCESSORIES TABLE TRAY |
| Product Code | FWZ |
| Date Received | 2020-02-12 |
| Model Number | #803 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INNOVATIVE MEDICAL PRODUCTS, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-12 |