BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGHTSCOPE RECTO MAXI LED AND BULB STERILE

    MDR report key: 10905737 · Received November 25, 2020

    Report

    Report Number
    3006680097-2020-00004
    Event Type
    Malfunction
    Date Received
    November 25, 2020
    Date of Event
    March 23, 2020
    Report Date
    November 24, 2020
    Manufacturer
    THD SPA
    Product Code
    FER
    PMA / PMN Number
    K121135
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE ON 21ST OCTOBER, 2020, THD SPA WAS REQUESTED BY FDA TO PROVIDE A REPORT ON A PRODUCT PROBLEM REPORTED TO FDA BY (B)(6) HOSPITAL MEDICAL CENTER. ACCORDING TO THE EVENT DESCRIPTION REPORTED IN THE USER FACILITY REPORT (NUMBER (B)(4)), THE PEEL PACK ON 3 (THREE) DEVICES OF LIGHTSCOPE RECTO MAXI LED & BULD STERILE PRESENTED PERFORATION ON THEIR MEDICAL ENVELOPE PACKAGE, THUS THE STERILITY OF THE PRODUCT WAS COMPROMISED. ACCORDING TO THE EVENT DESCRIPTION PROVIDED IN THE USER FACILITY REPORT, IT CAN BE ASSUMED THAT THE PERFORATION ON THE ENVELOPE OCCURRED FROM THE PAPER SIDE, SINCE IT IS THE MOST "FRAGILE" PART OF THE PACKAGE. SINCE THE DEVICES WERE NOT AVAILABLE FOR A DIRECT INVESTIGATION (NO INFORMATION RETRIEVED ON DEVICES AVAILABILITY), THD SPA STARTED AN INITIAL INVESTIGATION BASING ON THE REPORTED EVENT, IN PARTICULAR: 1) THE REVIEW OF ALL MANUFACTURING DATA AND DEVICE HISTORY RECORDS SINCE 2017 DIDN'T SHOW ANY DEVIATION IN PEELING TESTING AND IN-PROCESS CONTROL. ALL BATCHES HAVE BEEN RELEASED FOR DISTRIBUTION WITHOUT ANY DEROGATION SPECIFICALLY WITH REFERENCE TO ISSUES RELATED TO PRODUCT PACKAGING / STERILITY. 2) THE REVIEW OF MANUFACTURING DATA RELATED TO SUBJECT DEVICE (REF. 800118 - BATCH NUMBER 042119) DID NOT FOUND ANY ANOMALY AND DEVICES WERE RELEASED CONFORM FOR DISTRIBUTION ON 25/11/2019. MOREOVER LOT 042119 WAS SAMPLED FOR THE STERILITY TESTING (PART OF THE PERIODIC MONITORING ACTIVITY) RESULTING STERILE. 3) (B)(4). 4) THE LABELLING DATA FOR SUBJECT DEVICE ON PRIMARY AND SECONDARY PACKAGE LABEL REPORT THE SYMBOL "DO NOT USE IF THE PACKAGE IS DAMAGED"; MOREOVER IN THE INSTRUCTIONS FOR USE IS REPORTED TO VERIFY THE PACKAGE INTEGRITY AND TO NOT USE THE DEVICE IF THE PACKAGE IS BROKEN BECAUSE THE STERILITY CANNOT BE GUARANTEE. 5) THE REPORTED EVENT TAKES PLACE IN MARCH 2020 BUT IT HAS BEEN REPORTED ONLY IN SEPTEMBER 2020, THIS DELAY IN REPORTING IS ANOMALOUS AND DO NOT ALLOW TO PROPERLY INVESTIGATE THE EVENT. WE HAVEN'T THE OPPORTUNITY TO ANALYZE THE DEVICE IN ORDER TO UNDERSTAND IF THERE IS A RELATION BETWEEN THE PRODUCT AND THE DEFECT OR SIMPLY IF IT WAS DUE TO AN IMPROPER MANIPULATION OF THE SINGLE PACKAGE PRODUCT BEFORE THE USE. 6) THD SPA PERFORMED AN INVESTIGATION ON IN STOCK DEVICES OF ANOTHER PRODUCTION BATCH (LOT 057720) CHECKING THE INTEGRITY OF THE MEDICAL ENVELOPE PACKAGING WITHOUT FINDING ANY ANOMALIES. 7) THE SAME CONTROL HAS BEEN PERFORMED ALSO BY THD SPA ON DIFFERENT LOTS OF THE SAME DEVICES, ON 3 BOXES FOR 30 PIECES AND ALL THE PIECES HAVE BEEN FOUND WITHOUT ANY DAMAGE AT THE STERILE ENVELOPE. BASED ON THE ANALYSIS PERFORMED ON THE REPORTED EVENT, THD SPA CONSIDERS THAT THERE IS NO NEED TO TAKE ANY ACTION SINCE: · THIS IS A RARE AND ISOLATED CASE; · MANUFACTURING DATA AND IN-PROCESS CONTROLS DIDN'T SHOW ANY DEVIATION IN TERMS OF PRODUCT PACKAGE / STERILITY. 11. CORRECTED DATA WE UNDERLINE THAT IN THE USER FACILITY REPORT (B)(4) THE MANUFACTURER DATA ARE NOT CORRECTLY REPORTED, SINCE THERE IS A MIXING BETWEEN IMPORTER AND MANUFACTURER DATA. WE REPORT BELOW THE CORRECT DATA BOTH FOR MANUFACTURER AND IMPORTER: MANUFACTURER: (B)(4). ON THE BASIS OF THE ABOVE CONSIDERATION WE CAN CONCLUDE THAT THERE IS NO EVIDENCE OF A CERTAIN CONNECTION BETWEEN THE REPORTED EVENT AND A PRODUCT DEFECT, FOR THIS REASON WE CONSIDER THE POSSIBILITY OF REPORTING THIS EVENT TO BE EXCLUDED. HOWEVER, AS THERE IS SOME INACCURATE INFORMATION IN THE USER FACILITY REPORT, THD S.P.A. HAS DECIDED TO PRESENT THIS SUPPLEMENTARY REPORT IN ADDITION TO THE FORMAL RESPONSE AS REQUESTED BY FDA, WHICH WILL BE SENT STRICTLY BEFORE THE DEADLINE REQUESTED BY FDA IN THE COMMUNICATION TO THD SPA SENT BY (B)(4).

    Description of Event or Problem · 1

    THREE PIECES OF "THD LIGHTSCOPE RECTO MAXI LED AND BULB STERILE" (PRODUCT REF 800118, LOT NUMBER 042119) WERE FOUND WITH PRIMARY PACKAGE PERFORATED, THUS THE STERILITY OF THE PRODUCT WAS COMPROMISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1372279 LIGHTSCOPE RECTO MAXI LED AND BULB STERILE FAMILY OF DISPOSABLE, STERILE THD ANOSCOPE, PROCTOSCOPE, RECTOSCOPE & LIGHTSCOPE FER THD SPA 042119

    Patients

    Seq Age Sex Outcome Treatment
    1 Other