Description of Event or Problem · 1
PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT ON (B)(6) 2021 THAT OCCURRED IN THE OPERATING ROOM DURING USE IN (B)(6). THE REPORTED COMPLAINT THAT THE DISPOSABLE DEC [DISTAL END CAP] BECAME DISLODGED AT THE END OF THE PROCEDURE AS THE ENDOSCOPE WAS BEING WITHDRAWN. THE PROCEDURE INVOLVED PENTAX MEDICAL STERILE DISTAL END CAP ACCESSORY, MODEL OE-A63, LOT NUMBER 0021090. THE STERILE SINGLE USE DISTAL CAP WAS USED WITH PENTAX MEDICAL VIDEO DUODENOSCOPE MODEL ED34-I10T2, SERIAL NUMBER (B)(4). THE DEC WAS RETRIEVED FROM THE PATIENT WITH NO ISSUES USING A GASTROSCOPE(UNKNOWN MODEL AND SERIAL NUMBER) AND A RETRIEVAL NET(UNKNOWN MANUFACTURER, MODEL AND LOT NUMBER). THERE WAS NO CONSEQUENCE TO THE PATIENT REPORTED. PATIENT INFORMATION WAS NOT PROVIDED. THE CUSTOMER OWNED ENDOSCOPE WAS RECEIVED BY PENTAX (B)(4) FOR EVALUATION ON 09-MAR-2021 AND EVALUATED. THE ENDOSCOPE WAS FOUND TO BE OPERATIONAL AND WITHIN SPECIFICATION. ON 24-MAR-2021, A DEVICE HISTORY RECORD (DHR) REVIEW FOR PENTAX MEDICAL VIDEO DUODENOSCOPE MODEL ED34-I10T2, SERIAL NUMBER (B)(4) WAS PERFORMED UNDER (B)(4), THE DHR REVIEW CONFIRMED THE ENDOSCOPE WAS MANUFACTURED ON 04-MAR-2009 UNDER NORMAL CONDITIONS, PASSED ALL REQUIRED INSPECTIONS, AND WAS RELEASED ACCORDINGLY. ALSO, THERE WERE NO REWORKS OR CONCESSIONS AND THE DATES OF APPROVAL FOR SHIPMENT AND ACTUAL DATE SHIPPED WERE CONFIRMED FOR 04-MAR-2009. BASED ON THE PHONE CALL WITH THE PENTAX (B)(4) REPRESENTATIVE, THE INCIDENT APPEARS TO BE RELATED TO THE IMPROPER ATTACHMENT OF THE DEC MODEL OE-A63 ONTO THE ED34-I10T2 DUODENOSCOPE. THE USER KEPT THE ELEVATOR IN A DOWN POSITION WHILE ATTACHING OE-A63 WHICH SHOULD HAVE BEEN IN THE UP POSITION. THE ED34-I10T2 ENDOSCOPE OPERATION MANUAL PROVIDES DETAILS INSTRUCTION ON THE CORRECT ATTACHMENT OF THE END CAP. AS ABOVE, THE ROOT CAUSE OF THE PROBLEM APPEARS TO BE INCORRECT ATTACHMENT OF THE CAP AS DESCRIBED IN THE ED34-I10T2 OPERATION MANUAL. ADDITIONAL TRAINING WILL BE PROVIDED TO THE HOSPITAL STAFF BY PENTAX (B)(4) INC.