Description of Event or Problem · 1
OR FIELD LIGHT WAS BEING REPOSITIONED INTRAOPERATIVELY BY DR WHEN LIGHT HOUSING MADE CONTACT WITH IV POLE. GREASE CAP FELL OFF, LIGHT ONTO STERILE FIELD. THERE APPEARS TO BE A DESIGN PROBLEM: 1) GREASE CAP SPRINGS APPEAR TO ONLY HOLD CAP ON BY TENSION. POSSIBLY THERE SHOULD BE A GROOVE IN THE HOUSING FOR THE SPIRNG TO SIT IN. 2) SAFETY CABLE ATTACHMENT SCREW EYE BROKE NEAR HOLE. SCREW EYE APPEARS TO BE TO LARGE FOR SCREW. NO HARM TO PT.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-JAN-93. SERVICE PROVIDED BY: USER FACILITY BIOMEDICAL/BIOENGINEERING DEPARTMENT. SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION, VISUAL EXAMINATION. RESULTS OF EVALUATION: DESIGN - INADEQUATE. CONCLUSION: DEVICE FAILURE OCCURRED AND WAS RELATED TO EVENT, DEVICE FAILURE RELATED TO PATIENT CONDITION, DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE REPAIRED AND PUT BACK IN SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.