Description of Event or Problem · 1
PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT ON 16-NOV-2019, THAT OCCURRED DURING REPROCESSING ON (B)(6) 2019 IN (B)(6). THE REPORTED COMPLAINT THAT TWO TECHNICIANS UNDERWENT "EXPOSURE TO HIGH ISOPROPYL ALCOHOL VAPORS WHILE PRE-STERILIZING SCOPES DURING THE ALCOHOL FLUSH" INVOLVING MULTIPLE PENTAX MEDICAL I10 SERIES ENDOSCOPES. AFTER BEING MADE AWARE OF THE EVENTS ON THE FINAL DAY OF THE DEMO, 16-NOV-2019, PENTAX (B)(4) PROVIDED THE OPTION TO THE HOSPITAL TO NO LONGER USE ALCOHOL TO FLUSH AND MOVE TO AIR. THE SECOND TECHNICIAN WAS ASSESSED AND THEIR CONDITION WAS NOT CONSIDERED LIFE THREATENING AND WAS NOT ADMITTED TO THE HOSPITAL. NO TREATMENT WAS PROVIDED AT TIME OF THE EVENT. THE PATIENT WAS NOT RECALLED FOR FURTHER SCREENING AND THE TECHNICIAN IS STILL SYMPTOMATIC. WHEN ASKED IF THE TECHNICIAN WAS WEARING PROPER PPE(PERSONAL PROTECTIVE EQUIPMENT), INADEQUATE VENTILATION WAS NOTED. THE ENDOSCOPES INVOLVED WERE A GROUP OF DEMO UNITS REPROCESSED INCLUDING THE FOLLOWING MODELS AND SERIAL NUMBERS. EC38-I10NL = (B)(4) AND EG29-I10 = (B)(4). SINCE IT WAS A DEMONSTRATION, THE EXACT MODELS AND SERIAL NUMBERS PROCESSED BY EACH TECHNICIAN WERE NOT RECORDED IN DETAIL SO IT REMAINS UNCLEAR WHICH ENDOSCOPES WERE REPROCESSED BY WHICH TECHNICIAN. AS THERE WAS NO SUSPECTED MALFUNCTION OF THE PENTAX MEDICAL ENDOSCOPE ONLY ONE MDR REPORT WILL BE FILED FOR EACH TECHNICIAN FOR BOTH THE COLONOSCOPE AND GASTROSCOPE PRODUCT FAMILIES. DEVICE HISTORY RECORD(DHR) REVIEWS WERE PERFORMED FOR EACH ENDOSCOPE SERIAL NUMBER AND ARE DOCUMENTED BELOW. ON 13-DEC-2019, A DEVICE HISTORY RECORD(DHR) REVIEW WAS PERFORMED UNDER IVAI-19-120040, THE DHR REVIEW CONFIRMED ALL OF THE FOLLOWING ENDOSCOPES WERE MANUFACTURED UNDER NORMAL CONDITIONS, PASSED ALL REQUIRED INSPECTIONS, AND WERE RELEASED ACCORDINGLY. ALSO, THERE WERE NO REWORKS OR CONCESSIONS AND THE DATES OF APPROVAL FOR SHIPMENT AND ACTUAL DATE SHIPPED WERE CONFIRMED. BELOW ARE THE MANUFACTURING AND SHIP DATES FOR EACH SERIAL NUMBER: MODEL: EC38-I10NL, SERIAL NUMBER: (B)(4), MANUFACTURING DATE: 04-APR-2017, SHIPMENT DATE: 18-MAY-2017; MODEL: EC38-I10NL, SERIAL NUMBER: (B)(4), MANUFACTURING DATE: 21-APR-2017, SHIPMENT DATE: 18-MAY-2017; MODEL: EC38-I10NL, SERIAL NUMBER: (B)(4), MANUFACTURING DATE: 04-APR-2017, SHIPMENT DATE: 18-MAY-2017; MODEL: EC38-I10NL, SERIAL NUMBER: (B)(4), MANUFACTURING DATE: 10-OCT-2017, SHIPMENT DATE: 11-OCT-2017; MODEL: EC38-I10NL, SERIAL NUMBER: (B)(4), MANUFACTURING DATE: 13-OCT-2017, SHIPMENT DATE: 17-OCT-2017; MODEL: EC38-I10NL, SERIAL NUMBER: (B)(4), MANUFACTURING DATE: 13-OCT-2017, SHIPMENT DATE: 17-OCT-2017. MODEL: EG29-I10, SERIAL NUMBER: (B)(4), MANUFACTURING DATE: 24-JUN-2017, SHIPMENT DATE: 24-JUN-2017; MODEL: EG29-I10, SERIAL NUMBER: (B)(4), MANUFACTURING DATE: 11-JAN-2018, SHIPMENT DATE: 12-JAN-2018; MODEL: EG29-I10, SERIAL NUMBER: (B)(4), MANUFACTURING DATE: 11-JAN-2018, SHIPMENT DATE: 12-JAN-2018; MODEL: EG29-I10, SERIAL NUMBER: (B)(4), MANUFACTURING DATE: 11-JAN-2018, SHIPMENT DATE: 12-JAN-2018. THE INVESTIGATION IS CURRENTLY IN-PROCESS.