BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HISTOCORE PEGASUS

    MDR report key: 18814625 · Received March 1, 2024

    Report

    Report Number
    8010478-2024-00003
    Event Type
    Malfunction
    Date Received
    March 1, 2024
    Date of Event
    February 2, 2024
    Report Date
    May 29, 2024
    Manufacturer
    LEICA BIOSYSTEMS NUSSLOCH GMBH
    Product Code
    IEO
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AS PART OF OUR POST MARKET SURVEILLANCE, WE HAVE IDENTIFIED AN ISSUE RELATED TO POORLY PROCESSED OR DAMAGED BIOPSY TISSUE SPECIMENS ON THE HISTOCORE PEGASUS AND HISTOCORE PEGASUS PLUS SYSTEMS. THE PROBLEM IS ASSOCIATED WITH REAGENT LEVELS EXCEEDING THE MAXIMUM FILL LEVEL MARKS ON REAGENT BOTTLES OR IN THE PARAFFIN TANKS. THE OVERFILLING OF REAGENTS BY USERS, EXCESS REAGENT CARRIED FROM THE BASKET DURING INITIAL LOADING, OR EXCESSIVE REAGENT IN THE BIOPSY PADS/WRAPS CAN LEAD TO REAGENT LEVELS SURPASSING THE MAXIMUM FILL LEVEL MARK. AS A RESULT, EXCESS REAGENT MAY FLOW INTO OTHER BOTTLES THROUGH THE AIR MANIFOLD DURING A PROCESSING PROTOCOL, CAUSING CROSSCONTAMINATION. DUE TO THE FACT, THAT WE HAVE RECEIVED ONE (1) MORE MDR REGARDING THE SAFETY ISSUE DESCRIBED, IT HAS BEEN DECIDED TO INITIATE A FIELD ACTION. A CAPA HAS BEEN STARTED TO IDENTIFY DETAILED COUNTERMEASURES. THE FIRST STEP TO ADDRESS THIS ISSUE WILL BE TO SEND A FA-NOTICE TO THE CUSTOMER TO PROVIDE INFORMATION ABOUT THE POSSIBLY HAZARDOUS SITUATIONS REGARDING REAGENT OVERFILLING. IN ADDITION, THE FA-NOTICE WILL CONTAIN INFORMATION THAT LEICA BIOSYSTEMS SERVICE WILL CONTACT THE CUSTOMER TO PERFORM AN UPGRADE OF THE INSTRUMENT. THE SECOND STEP WILL BE THAT LEICA BIOSYSTEMS SERVICE WILL CONTACT THE CUSTOMER TO SCHEDULE THE UPGRADE OF THE INSTRUMENT WITH THE NEW MANIFOLD. THREE (3) ATTEMPTS WILL BE MADE TO CONTACT EACH CUSTOMER. THE GENERAL STRATEGY IS TO USE AT LEAST 2 DIFFERENT CHANNELS LIKE EMAIL AND PHONE CONTACT. THERE MAY BE SOME COUNTRY SPECIFIC EXEMPTIONS. EFFECTIVENESS CHECK/TARGET RESPONSE RATE: FOR THE COUNTRIES WHERE THIS FA IS REPORTABLE, WE AIM FOR A 100 % RESPONSE RATE. FOR COUNTRIES WHERE THE FA IS NOT REPORTABLE, WE AIM FOR A 75% RESPONSE RATE.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION OF THE INCIDENT IS CURRENTLY UNDERWAY AND A FOLLOW UP WILL BE SUBMITTED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE FOLLOWING THE INVESTIGATION.

    Description of Event or Problem · 0

    ON (B)(6) 2024 LEICA BIOSYSTEMS RECEIVED A COMPLAINT THAT THE CUSTOMER EXPERIENCED SUBOPTIMAL TISSUE PROCESSING ON THEIR HISTOCORE PEGASUS. AS A RESULT, 3 TISSUE SAMPLES NEED TO BE RECOLLECTED (2 GASTRIC BIOPSY SAMPLES AND 1 ESOPHAGEAL SAMPLE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1920239 HISTOCORE PEGASUS PROCESSOR, TISSUE, AUTOMATED IEO LEICA BIOSYSTEMS NUSSLOCH GMBH HISTOCORE PEGASUS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other