MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-27 for SCHUREMED GREAT WHITE PLATINUM 800-0342-PL-M manufactured by Schuerch Corporation.
[181160980]
Pt was having a transurethral resection of a bladder tumor, was supine on table with both legs supported with stirrups. (lithotomy position). At the end of the surgery, as the rn was taking the patient out of the stirrups, when the stirrup was lowered (while holding the stirrup boot), they heard a "snap" and the screw that holds the stirrup to the hydraulic lift, had broken. The patient's leg was supported at all times, and there was no injury or harm. After this incident, we found that we have no idea how old this device is, and it has had no preventative maintenance that we know of. We are going to remedy this, but the manufacturer booklet does not make any recommendations for preventative maintenance, although it indicates a 5 year life expectancy of the device. We would like schuremed to provide us with some recommendations.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9764002 |
| MDR Report Key | 9764002 |
| Date Received | 2020-02-27 |
| Date of Report | 2020-01-17 |
| Date of Event | 2019-12-12 |
| Report Date | 2020-01-17 |
| Date Reported to FDA | 2020-01-17 |
| Date Reported to Mfgr | 2020-02-27 |
| Date Added to Maude | 2020-02-27 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 3 |
| Brand Name | SCHUREMED GREAT WHITE PLATINUM |
| Generic Name | OPERATING ROOM ACCESSORIES TABLE TRAY |
| Product Code | FWZ |
| Date Received | 2020-02-27 |
| Model Number | 800-0342-PL-M |
| Catalog Number | 800-0342-PL-M |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SCHUERCH CORPORATION |
| Manufacturer Address | 452 RANDOLPH STREET ABINGTON MA 02351 US 02351 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-27 |