BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTAX

    MDR report key: 18603532 · Received January 29, 2024

    Report

    Report Number
    9610877-2024-00003
    Event Type
    Injury
    Date Received
    January 29, 2024
    Date of Event
    March 8, 2023
    Report Date
    February 28, 2024
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNATIONAL MEDICAL DEVICE REGULATORS FORUM (IMDRF) ADVERSE EVENT REPORTING. HEALTH EFFECT CLINICAL CODE: 2668 BOWEL PERFORATION. HEALTH EFFECT IMPACT CODE: 2368 SEDATION, 4641 UNEXPECTED MEDICAL INTERVENTION. MEDICAL DEVICE PROBLEM CODE: 1091 DEVICE REPROCESSING PROBLEM, 3026 UNINTENDED MOVEMENT. COMPONENT CODE: 527VALVE(S), 943 RING, 525 TUBE. TYPE OF INVESTIGATION: 4111 COMMUNICATION/INTERVIEWS, 3331 ANALYSIS OF PRODUCTION RECORDS. INVESTIGATION FINDINGS: 4229 DEVICE INCORRECTLY CLEANED DURING REPROCESSING. INVESTIGATION CONCLUSIONS: 19 CAUSE TRACED TO USE. EVALUATION SUMMARY: PENTAX MEDICAL EMEA RECEIVED THE FOLLOWING ADDITIONAL INFORMATION FROM (B)(6) HOSPITAL ON JANUARY 29, 2024. PATIENT 01: OCCURRENCE DATE: 24.11.2022. PATIENT'S HISTORY: DIVERTICULOSIS WITH STENOSIS FORMATION IN SIGMOID PLACE PERFORATION: COECUM; LONGITUDINAL TEAR; DIDN'T GO TO COECUM WITH A SCOOP SEDATION: DORMICUM AND FENTANYL. PATIENT DAMAGE: DIED AFTER LAPAROSCOPY AND LAPAROTOMY. PATIENT 02: OCCURRENCE DATE: 10.05.2023. PATIENT'S HISTORY: POSITIVE TEST VIA BVO; CT COLONOGRAPHY WITH POSSIBLE SUSPICION OF TUMOR/DIVERTICULITIS. PLACE PERFORATION: DISTAL TRANSVERSE; 2 LENGTH TEARS, EXTRALUMINAL. SEDATION: PROPOFOL. PATIENT DAMAGE: LAPAROSCOPY WITH STOMA PATIENT 03: OCCURRENCE DATE: 08.03.2023. PATIENT'S HISTORY: DIVERTICULITIS OF THE SIGMOID. PLACE PERFORATION: COECUM; DIDN'T GO TO COECUM WITH A SCOOP. SEDATION: PROPOFOL. PATIENT DAMAGE: LAPAROSCOPY AND DOUGLAS FIR ABSCESS. PATIENT 04: OCCURRENCE DATE: 01.06.2023. PATIENT'S HISTORY: POSITIVE TEST VIA BVO; PLACE PERFORATION: COECUM; 2 POLYPS REMOVED 'COLD' COECUM; HOLE. SEDATION: PROPOFOL. PATIENT DAMAGE: LAPAROTOMY. RESULTS OF THE INVESTIGATION THAT MAINTENANCE, CLEANING AND DISINFECTION WERE NOT DONE ACCORDING TO INSTRUCTIONS FOR USE AND VISIBLY FAULTY VALVES WERE NOT REMOVED FROM CIRCULATION. THERE WERE NO DEFECTS WITH THE ENDOSCOPE. A DEVICE HISTORY RECORD(DHR) REVIEW WAS PERFORMED BY THE MANUFACTURER. THE DHR REVIEW CONFIRMED THE ENDOSCOPE WAS MANUFACTURED PENTAX MEDICAL PENANG ON 16-DEC-2019 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 ON 16-DEC-2019. 9610877-2024-00001_EC38-I10F2_L0034Z0172_PATIENT 01. 9610877-2024-00002_EC34-I10TF_A110082_PATIENT 02. 9610877-2024-00003_EC38-I10F2_L0034Z0115_PATIENT 03. 9610877-2024-00017_EC38-I10F2_L0034Z0115_PATIENT 04. PENTAX MEDICAL HAS NOT RECEIVED ANY FURTHER INFORMATION FOR THIS EVENT AND THEREFORE, CONSIDERS THIS MEDWATCH REPORT CLOSED.

    Additional Manufacturer Narrative · 0

    H6 CONTINUED: INTERNATIONAL MEDICAL DEVICE REGULATORS FORUM (IMDRF) ADVERSE EVENT REPORTING HEALTH EFFECT CLINICAL CODE: 2668 BOWEL PERFORATION HEALTH EFFECT IMPACT CODE: 4648 INSUFFICIENT INFORMATION MEDICAL DEVICE PROBLEM CODE: 1091 DEVICE REPROCESSING PROBLEM, 3026 UNINTENDED MOVEMENT COMPONENT CODE: 527VALVE(S), 943 RING TYPE OF INVESTIGATION: 4118 TYPE OF INVESTIGATION NOT YET DETERMINED INVESTIGATION FINDINGS: 3233 RESULTS PENDING COMPLETION OF INVESTIGATION INVESTIGATION CONCLUSIONS: 11 CONCLUSION NOT YET AVAILABLE THIS DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES. PENTAX MEDICAL EMEA PERFORMED GOOD FAITH EFFORTS TO GATHER ADDITIONAL INFORMATION REGARDING THE PATIENT'S MEDICAL INTERVENTIONS AND PATIENT OUTCOMES, BUT NO INFORMATION IS AVAILABLE AT THIS TIME. THE CURRENT INVESTIGATION IS AS FOLLOWS. - THERE IS PROBABLY A BURR IN THE VALVE SEAT OF THE VALVES. - BURRS IN THE VALVE SEAT CAN DAMAGE THE VALVE O-RINGS - WATER CAN FLOW UNCONTROLLABLY THROUGH THE DEFECTIVE O-RINGS INVESTIGATION IS IN-PROCESS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION. 9610877-2024-00001_EC38-I10F2_L0034Z0172_PATIENT 01 9610877-2024-00002_EC34-I10TF_A110082_PATIENT 02 9610877-2024-00003_EC38-I10F2_L0034Z0115_PATIENT 03

    Description of Event or Problem · 0

    ON 04-JAN-2024 THE HEALTH AND YOUTH CARE INSPECTORATE, THE COMPETENT AUTHORITY REGARDING MEDICAL DEVICES IN THE NETHERLANDS, NOTIFIED PENTAX MEDICAL THE INSPECTORATE HAD BECOME AWARE OF SEVERAL SERIOUS INCIDENTS IN THE NETHERLANDS INVOLVING PENTAX ENDOSCOPES DURING USE. THE USER FACILITY REPORTED THAT SEVERAL PENTAX ENDOSCOPE PERFORATIONS OCCURRED. ROOTCAUSE ANALYSIS CONCLUSIONS BY THE HOSPITAL; THE PERFORATIONS ARE LIKELY DUE TO IMPROPERLY FUNCTIONING VALVES. THE HEALTHCARE FACILITY ANALYSIS REVEALED THAT MAINTENANCE, CLEANING AND DISINFECTION WERE NOT DONE ACCORDING TO INSTRUCTIONS FOR USE. THE ANALYSIS ALSO REVEALED THAT THIS FACILITY CONTINUED TO USE A FAULTY VALVE FOR ENDOSCOPY, EVEN THOUGH THIS FAULT OF VALVE WAS VISIBLY DETECTED. ADDITIONALLY, THE ANALYSIS ALSO CONCLUDES THAT THE PROBABLE ROOT CAUSE IS USER ERROR, RATHER THAN A MEDICAL DEVICE DEFECT. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2549449 PENTAX VIDEO COLONO SCOPE FDF HOYA CORPORATION PENTAX TOKYO OFFICE EC38-I10F2

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R