Description of Event or Problem · 1
THE PEG GUIDEWIRE WAS BEING INTRODUCED THROUGH A SMALL INCISION INTO THE STOMACH WHILE BEING OBSERVED THROUGH THE SCOPE. ONCED THE GUIDEWIRE WAS SNARED FROM THE SCOPE AND BROUGHT UP THROUGH THE ESOPHAGUS IT WAS NOTED THAT THE INFLEXIBLE END WAS SNARED RATHER THAN FLEXIBLE. INJURY TO THE PATIENT WAS MINOR, A SLIGHT ABRASION TO THE ESOPHAGUS. THE INFLEXIBLE END OF THE GUIDEWIRE HAD BEEN PACKAGED TO BE ADVANCED FIRST. THE FLEXIBLE END SHOULD HAVE BEEN EXPOSED TO ADVANCE FIRST. THE MANUFACTURER REPRESENTATIVE WAS NOTIFIED OF THIS PACKAGING ERROR. ALL OF THE SAME SERIAL NUMBER SETS WERE RETURNED TO BARDDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. 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. RESULTS OF EVALUATION: MANUFACTURING. CONCLUSION: OTHER. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: MAYBE. CORRECTIVE ACTIONS: OTHER. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.