BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORCA

    MDR report key: 17744967 · Received September 14, 2023

    Report

    Report Number
    3005099803-2023-04940
    Event Type
    Malfunction
    Date Received
    September 14, 2023
    Date of Event
    August 1, 2023
    Report Date
    December 6, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    ODC
    UDI-DI
    08714729981589
    PMA / PMN Number
    K182275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: THE EXACT DATE OF THE EVENT IS UNKNOWN. THE PROVIDED EVENT DATE WAS CHOSEN AS A BEST ESTIMATE BASED ON THE DATE THAT THE MANUFACTURER BECAME AWARE OF THE EVENT. BLOCK H6: IMDRF DEVICE CODE A020513- CAPTURES THE REPORTABLE EVENT OF PACKAGING SEAL COMPROMISED.

    Additional Manufacturer Narrative · 0

    : THE EXACT DATE OF THE EVENT IS UNKNOWN. THE PROVIDED EVENT DATE WAS CHOSEN AS A BEST ESTIMATE BASED ON THE DATE THAT THE MANUFACTURER BECAME AWARE OF THE EVENT. IMDRF DEVICE CODE A020513- CAPTURES THE REPORTABLE EVENT OF PACKAGING SEAL COMPROMISED. BLOCK H10: INVESTIGATION RESULTS THE RETURNED ORCAPOD 4 WAS ANALYZED. VISUAL EVALUATION FOUND THAT ORCAPOD SETS CONFIRMED THAT THERE WERE PLASTIC DEFORMATIONS ON THE PACKAGING AND FADED LABELS ON THE DEVICE POUCH. HOWEVER, THE REPORTED SEAL COMPROMISE WAS NOT CONFIRMED. NO OTHER PROBLEMS WERE NOTED. THE REPORTED COMPLAINT OF SEAL COMPROMISE COULD NOT CONFIRM. HOWEVER, REGARDING DAMAGED PACKAGING AND LABEL DAMAGED THE REPORTED COMPLAINT WAS CONFIRMED. IT IS POSSIBLE THAT THE PACKAGING AND INDIVIDUAL LABELS ON THE DEVICE POUCHES WERE DAMAGED DURING TRANSPORT OR HEAT AFFECTED THE TRAYS CAUSING THE DEFORMATION OF PLASTIC AND THE LABELING. BASED ON ALL AVAILABLE INFORMATION AND ANALYSIS OF THE RETURNED DEVICE, THE MOST PROBABLE CAUSE IS CAUSE TRACED TO TRANSPORT/STORAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN ORCAPOD 4 WAS RECEIVED ON AN UNKNOWN DATE. UPON OPENING THE NEW BOX THERE WAS EVIDENCE OF THE INNER PACKAGING BEING HEAT-AFFECTED. THE STERILITY OF THE DEVICE WAS COMPROMISED DUE TO PACKAGING DAMAGE. THERE WAS NO PATIENT INVOLVEMENT, AND THIS DEVICE WAS NOT USED IN A PROCEDURE. NOTE: A PHOTO OF THE DEVICE PACKAGING WAS PROVIDED BY THE CUSTOMER AND SHOWED THE PACKAGING DAMAGED AND THE LABEL DAMAGED. INITIAL REVIEW OF A PHOTO OF THE COMPLAINT DEVICE RECEIVED DOES NOT APPEAR TO SHOW A STERILE BARRIER BREACH, HOWEVER PRODUCT IS IN TRANSIT TO THE INVESTIGATION SITE AND FULL ANALYSIS WILL BE COMPLETED TO DETERMINE IF THE BARRIER IS INDEED BREACHED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN ORCAPOD 4 WAS RECEIVED ON AN UNKNOWN DATE. UPON OPENING THE NEW BOX THERE WAS EVIDENCE OF THE INNER PACKAGING BEING HEAT-AFFECTED. THE STERILITY OF THE DEVICE WAS COMPROMISED DUE TO PACKAGING DAMAGE. THERE WAS NO PATIENT INVOLVEMENT, AND THIS DEVICE WAS NOT USED IN A PROCEDURE. NOTE: A PHOTO OF THE DEVICE PACKAGING WAS PROVIDED BY THE CUSTOMER AND SHOWED THE PACKAGING DAMAGED AND THE LABEL DAMAGED. INITIAL REVIEW OF A PHOTO OF THE COMPLAINT DEVICE RECEIVED DOES NOT APPEAR TO SHOW A STERILE BARRIER BREACH, HOWEVER PRODUCT IS IN TRANSIT TO THE INVESTIGATION SITE AND FULL ANALYSIS WILL BE COMPLETED TO DETERMINE IF THE BARRIER IS INDEED BREACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2283542 ORCA ENDOSCOPE CHANNEL ACCESSORY ODC BOSTON SCIENTIFIC CORPORATION SUV-629-50 0031582653 08714729981589

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown