[3654238]
Allen medical systems received a medwatch report (uf/importer report # (b)(4)) from fda which had been submitted in regard to an event reported to occur at winnie palmer hospital for women and babies, orlando fl. The following event was reported: when a yellowfin stirrup (right-hand side) was raised upon completion of a surgical procedure so that the operating room table foot section could be replaced onto the table, the stirrup and rail clamp detached from the table with the pt's leg secured to the stirrup. Operating room staff immediately took hold of the pt's leg to prevent injury. When the stirrup / rail clamp was reattached to the bed, it was noted that the clamp tightening knob was "very loose". The pt showed no sign of trauma or deformity. An x-ray image was taken and was normal. The event was not reported to allen medical by the user. The observation made by the user prior to reattaching the stirrup / clamp, that the tightening knob was noted to be very loose, indicates that user error is a probable cause of detachment of the stirrup as the knob should always be verified to be firmly tightened prior to the start of a procedure as specified in the instructions for use supplied with the device. Contact attempts with the customer have been initiated to request additional information and return of the device for evaluation if possible. A follow-up medwatch report will be submitted should any relevant investigatory results be obtained.
Patient Sequence No: 1, Text Type: D, B5