BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTAX

    MDR report key: 17744161 · Received September 14, 2023

    Report

    Report Number
    2518897-2023-00047
    Event Type
    Injury
    Date Received
    September 14, 2023
    Date of Event
    September 1, 2023
    Report Date
    September 14, 2023
    Manufacturer
    HOYA CORPORATION PENTAX
    Product Code
    FDF
    UDI-DI
    04961333172085
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    F10 CONTINUED: INTERNATIONAL MEDICAL DEVICE REGULATORS FORUM (IMDRF) ADVERSE EVENT REPORTING HEALTH EFFECT CLINICAL CODE: 1685 ABDOMINAL PAIN, 1987 INTERNAL ORGAN PERFORATION HEALTH EFFECT IMPACT CODE: 4641 UNEXPECTED MEDICAL INTERVENTION MEDICAL DEVICE PROBLEM CODE: 2993 ADVERSE EVENT WITHOUT IDENTIFIED DEVICE OR USE PROBLEM COMPONENT CODE: 4755 PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE. INVESTIGATION IS IN-PROCESS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION. FILE ATTACHMENTS.

    Additional Manufacturer Narrative · 0

    CORRECTION INFORMATION: F7: FOLLOW UP #01. EVALUATION SUMMARY: BASED ON THE GOOD FAITH EFFORT(GFE) RESPONSE RECEIVED VIA EMAIL ON 14-SEP-2023, PENTAX MEDICAL WAS PROVIDED ADDITIONAL PATIENT INFORMATION AS WELL AS TREATMENT DETAILS. THE PATIENT WAS RECALLED AND UNDERWENT AN OPEN SIGMOID COLON RESECTION THAT WAS COMPLETED ON (B)(6) 2023. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2023. THE PENTAX MEDICAL COLONOSCOPE MODEL NUMBER EC38-I10L, SERIAL NUMBER (B)(6) WAS ORIGINALLY REPORTED AS WORKING WITHIN SPECS WITH NO ISSUES DURING THE FIRST USE CASE. ADDITIONALLY, THE DEVICE WAS NOT REMOVED FROM CIRCULATION IMMEDIATELY AFTER THE EVENT OCCURRED AND REMAINED IN INVENTORY AND NOTED AS OPERATIONAL AT THE MADISON MEMORIAL HOSPITAL. A DEVICE HISTORY RECORD(DHR) REVIEW WAS PERFORMED BY THE MANUFACTURER. THE DHR REVIEW CONFIRMED THE ENDOSCOPE WAS MANUFACTURED BY PENTAX MEDICAL MIYAGI ON 17-MAY-2023 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 ON 05-JUN-2023 AND ACTUAL DATE SHIPPED WERE CONFIRMED ON 06-JUN-2023. BASED ON THE PROVIDED INFORMATION AND INVESTIGATION, THE ROOT CAUSE FOR THE PATIENT INJURY WAS NOT ABLE TO BE DETERMINED. PENTAX MEDICAL HAS NOT RECEIVED ANY FURTHER INFORMATION FOR THIS EVENT AND THEREFORE, CONSIDERS THIS MEDWATCH REPORT CLOSED.

    Description of Event or Problem · 0

    PENTAX MEDICAL BECAME AWARE OF AN EVENT THAT OCCURRED ON (B)(6) 2023 IN THE OPERATING ROOM DURING USE IN THE UNITED STATES INVOLVING PENTAX MEDICAL VIDEO COLONOSCOPE, MODEL EC38-I10L, SERIAL NUMBER (B)(6). THE USER FACILITY REPORTED THAT A PATIENT COMPLAINED OF ABDOMINAL PAIN AFTER THEIR PROCEDURE. THE PATIENT WAS SENT TO SURGERY ON THE SAME DAY IN ORDER TO REPAIR A PERFORATED COLON. THE PENTAX MEDICAL SALES REPRESENTATIVE NOTED THAT THE NEW DEVICE WAS FUNCTIONING PROPERLY AND WORKING WITHIN SPECIFICATIONS WITH NO ISSUES. 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
    391440 PENTAX VIDEO COLONOSCOPE, FDF HOYA CORPORATION PENTAX EC38-I10L 04961333172085

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Required Intervention