BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 9576942 · Received January 10, 2020

    Report

    Report Number
    9610877-2020-00016
    Event Type
    Malfunction
    Date Received
    January 10, 2020
    Report Date
    December 8, 2022
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    EQN
    PMA / PMN Number
    K162151
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: WE ASKED THE CUSTOMER WHETHER THE CULTURE TEST WAS NECESSARY OR NOT, BUT WE DID NOT RECEIVE A REPLY AND COULD NOT OBTAIN ANY INFORMATION. THE REASON FOR REPORTING THE SUSPICION OF BIOFILM IS UNKNOWN BECAUSE INFORMATION INCLUDING THE CUSTOMER'S USE CASE WAS NOT OBTAINED. THERE HAVE BEEN NO SIMILAR COMPLAINTS IN THIS SCOPE, AND IT HAS BEEN CONFIRMED THAT THERE WILL BE NO PROBLEMS IF REPROCESSING IS DONE ACCORDING TO IFU. SINCE THERE HAVE BEEN NO SIMILAR COMPLAINTS FROM THE FACILITY SINCE THEN, IT IS DETERMINED THAT THE EQUIPMENT WAS NOT THE CAUSE. CORRECTION INFORMATION. G6: FOLLOW UP #1. H2: TYPE OF FOLLOW UP. H6: CODING CHANGED BASED ON THE INVESTIGATION RESULT.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE REPORTED COMPLAINT WAS CALLED INTO PENTAX MEDICAL CUSTOMER SERVICE ON 12-DEC-2019, AND REPORTED BIOFILM AND CORROSION FOUND DURING PRE-INSPECTIONAL CHECK OF THE ENDOSCOPE AND WAS DOCUMENTED AS "POTENTIAL ENDOSCOPE CONTAMINATION" INVOLVING A PENTAX MEDICAL VIDEO NASO-PHARYNGO-LARYNGOSCOPE(NPL). NO SERIOUS INJURY OR DEATH OF A PATIENT OR USER, OR DELAY IN THE PROCEDURE WHICH WOULD REQUIRE MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER OWNED VIDEO NASO-PHARYNGO-LARYNGOSCOPE(NPL) WAS RECEIVED BY PENTAX MEDICAL FOR EVALUATION ON 19-DEC-2019. THE NPL WAS INSPECTED BY PENTAX MEDICAL SERVICE ON 27-DEC-2019, AND THE FOLLOWING INSPECTION FINDINGS WERE DOCUMENTED: SEGMENT CRUSHED, PASSED DRY LEAK TEST, SHORT UMBILICAL CABLE BUCKLE AT UMBILICAL CONNECTOR SIDE, PASSED WET LEAK TEST, PVE ELECTRICAL CONNECTOR FRAME MILD CORROSION. PENTAX MEDICAL VIDEO NASO-PHARYNGO-LARYNGOSCOPE(NPL), VNL-1570STK, SERIAL NUMBER (B)(4), HAS BEEN ROUTINELY SERVICED AT A PENTAX FACILITY SINCE THE DEVICE WAS PUT INTO SERVICE ON 30-APR-2009. THE DUODENOSCOPE UNDERWENT REPAIRS INCLUDING THE FOLLOWING COMPONENTS: INSERTION FLEX TUBE W/SEG PB-FREE, DISTAL END ASSY WITH TUBE, BENDING RUBBER, BIOPSY INLET T-PIECE, BIOPSY INLET BARREL, O-RINGS AND SEALS, INSERTION/S-NIPPLE ATTACHING SCREW, O-RING(1.25X3.5), SUCTION CONNECTION TUBE, O-RING(1.2X3.5). THE NASO-PHARYNGO-LARYNGOSCOPE IS PENDING REPAIR COMPLETION, RESAMPLING AND FINAL QC APPROVAL AS OF 10-JAN-2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41751 PENTAX VIDEO NASO-PHARYNGO-LARYNGOSCOPE EQN HOYA CORPORATION PENTAX TOKYO OFFICE VNL-1570STK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown