BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 9512493 · Received December 23, 2019

    Report

    Report Number
    9610877-2019-01570
    Event Type
    Malfunction
    Date Received
    December 23, 2019
    Date of Event
    December 2, 2019
    Report Date
    December 6, 2019
    Product Code
    FDF
    PMA / PMN Number
    K131855
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REFER TO MDRS: 9610877-2019-01569 FOR THE 2ND PROCEDURE, PATIENT RISK - USED ON PATIENT DURING PROCEDURE WITH ENDOCLIP INSIDE ENDOSCOPE.

    Description of Event or Problem · 1

    PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT ON 06-DEC-2019 FROM CENTER ADMINISTRATOR OFFICER AT ENDOSCOPY CENTER OF (B)(6). THE REPORTED COMPLAINT WAS THAT A PHYSICIAN ATTEMPTED TO RETRIEVE AN ENDOCLIP (UNKNOWN MODEL AND LOT NUMBER) USED IN A PROCEDURE BUT WAS UNSUCCESSFUL IN LOCATING IT AFTER THAT PROCEDURE INVOLVING A PENTAX MEDICAL VIDEO COLONOSCOPE, MODEL EC-3490LI, SERIAL NUMBER (B)(4). HE DID SUCCESSFULLY PASS DEVICES AFTER TRYING TO RETRIEVE THE CLIP SO THE ENDOSCOPE WAS SENT TO REPROCESSING WHERE THE ENDOSCOPE WAS FULLY REPROCESSED VIA A MANUAL CLEANING AND HIGH LEVEL DISINFECTANT, STERIS SYSTEM 1E. THE ENDOSCOPE WAS USED ON ANOTHER PATIENT AFTERWARDS WITH NO INTERVENTIONAL THERAPY THEN CLEANED AND REPROCESSED AGAIN. DURING THE PRE-INSPECTION CHECK PRIOR TO A THIRD CASE, THE CLIP CAME OUT OF THE ENDOSCOPE. THERE WAS NO PATIENT INVOLVEMENT IN THE THIRD CASE. THE VIDEO COLONOSCOPE WAS RECEIVED BY PENTAX MEDICAL FOR EVALUATION ON 04-DEC-2019 UNDER RETURN MATERIAL AUTHORIZATION NUMBER (B)(4). THE VIDEO COLONOSCOPE WAS INSPECTED BY PENTAX MEDICAL SERVICE ON (B)(6) 2019 AND THE FOLLOWING INSPECTION FINDINGS WERE DOCUMENTED: INSERTION TUBE BUCKLES AT END OF ROOT BRACE, FAILED WET LEAK TEST, LEAK AT UMBILICAL CABLE, PVE ELECTRICAL CONNECTOR FRAME HAS SEVERE CORROSION, FAILED DRY LEAK TEST, INSERTION TUBE BUCKLES AT STAGE 1, UMBILICAL CABLE SINGLE BUCKLED UNDER PVE ROOT BRACE, OPERATION CHANNEL- PRIMARY, KINKED AT END OF INSERTION ROOT, SUCTION CYLINDER PIPES DEFORMED. THE COLONOSCOPE UNDERWENT REPAIRS INCLUDING THE FOLLOWING COMPONENTS: O-RINGS AND SEALS, ADJUSTING COLLAR, ANGLE WIRE ASSY, BENDING RUBBER, DISTAL ATTACHING PLATE, INSERTION FLEX TUBE, SEGMENT ASSY ATTACHING SCREW, RL PULLEY ASSY, UD PULLEY ASSY, LIGHT GUIDE CABLE, DISTAL END ASSY WITH TUBES, AIR/WATER SUPPLY TUBE LG, JET SUPPLY TUBE LG, SUCTION CHANNEL LG, BIOPSY INLET T-PIECE, OBJECTIVE LENS UNIT PB-FREE. A RESPONSE TO THE PENTAX MEDICAL GOOD FAITH EFFORT WAS RECEIVED VIA EMAIL FROM THE REPORTING FACILITY ON (B)(6) 2019 AND THEY CONFIRMED THAT THE INITIAL PROCEDURE WHEN THE ENDOCLIPS WERE USED WAS (B)(6) 2019. THE MODEL AND LOT NUMBER OF THE ENDOCLIP WAS NOT PROVIDED AND REMAINS UNKNOWN. THE SECOND PROCEDURE OCCURRED ON (B)(6) 2019. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE (B)(6) YEAR OLD, (B)(6) POUND, FEMALE PATIENT, WITH UNIQUE ID (B)(6), REFUSED THE OFFER FOR FURTHER SCREENING. THE THIRD PROCEDURE WAS SCHEDULED FOR (B)(6) 2019, BUT THE ENDOCLIP WAS DISCOVERED DURING PRE-INSPECTIONAL CHECK AND HAD NO PATIENT INVOLVEMENT. PENTAX MEDICAL VIDEO COLONOSCOPE, MODEL EC-3490LI, SERIAL NUMBER (B)(4), HAS BEEN ROUTINELY SERVICED AT A PENTAX FACILITY SINCE THE DEVICE WAS PUT INTO SERVICE ON (B)(6) 2009. THE VIDEO COLONOSCOPE IS CURRENTLY AWAITING QC FINAL APPROVAL AND ORGANIC RESAMPLING AS OF 23-DEC-2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1305095 PENTAX VIDEO COLONOSCOPE FDF EC-3490LI

    Patients

    Seq Age Sex Outcome Treatment
    1