Description of Event or Problem · 1
THIS INFORMATION RELATES TO AN INTERNATIONAL EVENT AS PUBLISHED IN A JOURNAL ARTICLE {GOLDSCHMIEDT, MARKUS MD. " A SAFETY MANEUVER FOR PLACING OVERTUBE DURING ENDOSCOPIC VARICEAL LIGATION." GASTROENTEROLOGY ENDOSCOPY VOL. 38, NO. 3, 1992:399,400.} THEREFORE, TO DATE, WE HAVE BEEN UNABLE TO ESTABLISH ANY DETAILED INFORMATION. THE OVERTUBE WAS USED DURING AN ENDOSCOPIC LIGATION. WHEN THE OVERTUBE WAS PLACED IN THE ESOPHAGUS COAXIALLY WITH THE ENDOSCOPE, A PERFORATION OCCURRED. IT IS UNKNOWN HOW THE PATIENT WAS MANAGED AFTER THE EVENTINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. INVALID DATA - REGARDING 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. INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED. INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.