MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-06-04 for SHAMPINE (AMATECH ACCESSORY) * manufactured by Mdt Diagnostic Company.
[110779]
During preparation for surgery the pt was placed on the surgical table in the dorsal lithotomy position. The pt's legs were placed in the surgical table accessory knee crutch stir-ups. During preparation the right clamp securing the stir-up which held the pt's right leg broke into two pieces. The or nurse reporting the incident indicated she heard a pop and the stir-up clamp broke and the pt's leg fell onto the surgical operating table. The or nurse immediately lifted the pt's leg and repositioned a new clamp.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 171939 |
| MDR Report Key | 171939 |
| Date Received | 1998-06-04 |
| Date of Report | 1998-05-20 |
| Date of Event | 1998-05-08 |
| Date Facility Aware | 1998-05-08 |
| Report Date | 1998-05-20 |
| Date Reported to Mfgr | 1998-05-20 |
| Date Added to Maude | 1998-06-12 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHAMPINE (AMATECH ACCESSORY) |
| Generic Name | SURGICAL TABLE ACCESSORY STIR-UP CLAMP |
| Product Code | EYD |
| Date Received | 1998-06-04 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Age | 5 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 167201 |
| Manufacturer | MDT DIAGNOSTIC COMPANY |
| Manufacturer Address | 7371 SPARTAN BLVD. EAST PO BOX 40488 NORTH CHARLESTON SC 29411 US |
| Baseline Brand Name | SHAMPINE (AMATECH ACCESSORY) |
| Baseline Generic Name | SURGICAL TABLE ACCESSORY STIR-UP CLAMP |
| Baseline Model No | S/N 26129 |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-06-04 |