MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-22 for TURBETT SURGICAL POD manufactured by Turbett Surgical.
[100953834]
Pt for right tka, filter on turbett surgical pod noted to have hole, instrument container returned to central processing for resterilization. Director of surgical services and operations manager of central processing aware and contacted turbett surgical. Operations manager, turbett surgical revietabs were added to help support the screen from distorting. All units within the hospital were updated. Wed the 3 units that produced holes in the filters. Two more
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5075465 |
| MDR Report Key | 7292616 |
| Date Received | 2018-02-22 |
| Date of Report | 2018-02-21 |
| Date of Event | 2018-02-07 |
| Date Added to Maude | 2018-02-23 |
| 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 | TURBETT SURGICAL POD |
| Generic Name | SURGICAL CONTAINER |
| Product Code | FRG |
| Date Received | 2018-02-22 |
| Returned To Mfg | 2018-02-08 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TURBETT SURGICAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-22 |