BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHARPOINT

    MDR report key: 16450049 · Received February 27, 2023

    Report

    Report Number
    3010692967-2023-00009
    Event Type
    Injury
    Date Received
    February 27, 2023
    Date of Event
    January 23, 2023
    Report Date
    February 27, 2023
    Manufacturer
    SURGICAL SPECIALTIES
    Product Code
    EMF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE LOT NUMBER OF THE DEVICE WAS NOT DISCLOSED. A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED TO CONFIRM IF THERE WERE QUALITY ISSUES NOTED THROUGHOUT INCOMING INSPECTION, MANUFACTURING, IN-PROCESS OR FINAL INSPECTION PROCESSES. A REVIEW OF THE COMPLAINT DATABASE CONFIRMED THERE WERE NO OTHER COMPLAINTS RECEIVED FOR THIS ITEM CODE FOR A KNIFE BEING RECEIVED WITHOUT A FOAM PROTECTOR OR AN INJURY OCCURRING PRIOR TO THE SURGERY. NO SAMPLES WERE RETURNED FOR REVIEW. A PHOTO OF THE PACKAGE, DEVICE OR THE TECH''S WOUND WERE NOT PROVIDED FOR REVIEW. IF PHOTOS OR SAMPLES BECOME AVAILABLE AT A LATER DATE, THEY WILL BE REVIEWED AND THE RESULTS OF THE ANALYSIS WILL BE INCLUDED IN THE FILE. ITEM 72-1551 IS PACKAGED WITH A FOAM PROTECTOR TO COVER THE BLADE COMPONENT. THIS PROTECTOR IS UTILIZED TO PROTECT THE BLADE FROM DAMAGE AND TO HOLD THE KNIFE SECURE WITHIN THE BLISTER PACKAGE. ALL PACKAGES/BLISTER'S ARE INSPECTED PRIOR TO LOADING THEM INTO THE BOX OF SIX (6). ¿THE WAY IN WHICH A SURGICAL BLADE IS HANDLED PRIOR TO USE CAN AFFECT THE WAY IN WHICH THE BLADE PERFORMS DURING USE. TAKE CARE TO ENSURE THE CUTTING EDGE OF A BLADE DOES NOT BECOME DAMAGED ONCE REMOVED FROM ITS PACKAGING. THIS INCLUDES DROPPING THE BLADE INTO A METAL BOWL OR OTHER CONTAINER THAT COULD POTENTIALLY DULL THE BLADE. IT ALSO INCLUDES NOT GRIPPING THE BLADE WITH A FORCEPS OR NEEDLE CLAMP ACROSS THE CUTTING EDGE OF THE BLADE. KEEP IN MIND THAT SURGICAL BLADES ARE SHARP INSTRUMENTS. TAKE PROPER PRECAUTIONS IN HANDLING THE BLADE SO AS NOT TO INJURE YOURSELF OR OTHERS BEFORE, DURING, OR AFTER USE. SEEK PROPER TRAINING AND INSTRUCTION ON USE BEFORE HANDLING. THIS DEVICE IS SINGLE USE ONLY. REUSE OF DEVICE COULD RESULT IN INFECTION/ CONTAMINATION AND/ OR DEVICE FAILURE WHICH COULD LEAD TO PATIENT HARM. ¿ DURING USE AVOID TWISTING, BENDING, OR PUTTING EXCESSIVE FORCE OR STRAIN ON THE BLADE IN ORDER TO HELP PREVENT BREAKAGE. ¿ IF BLADE BECOMES DULL OR BREAKS, DISPOSE AND REPLACE PRODUCT. ¿ DO NOT USE PRODUCT IF PRODUCT IS DAMAGED OR PARTICULATE IS FOUND IN STERILE PACKAGING¿. WITHOUT RECEIVING THE FINISHED GOOD LOT NUMBER TO REVIEW MANUFACTURING RECORDS, RECEIVING STERILE DEVICES FROM THE SAME LOT FOR REVIEW OF THE DEVICES/PACKAGING, RECEIVING PHOTOS OF THE DEVICE HANDLED BY THE TECHNICIAN, PHOTOS OF THE WOUND SUSTAINED, OR RECEIVING DETAILED INFORMATION REGARDING THE EXACT CONTENTS OF THE PACKAGE (WAS THE KNIFE BLADE PROTECTED BY A FOAM PROTECTOR WHEN OPENED?), METHOD UTILIZED TO REMOVE THE DEVICE FROM THE PACKAGING/FOAM PROTECTOR, DETAILS OF THE INJURY SUSTAINED, OR INTERVENTION REQUIRED TO TREAT THE INJURY, A THOROUGH INVESTIGATION CANNOT BE PERFORMED TO DETERMINE THE ROOT CAUSE FOR THE INJURY.

    Description of Event or Problem · 0

    WE WERE NOTIFIED OF A COMPLAINT FROM THE DISTRIBUTOR STATING THE UNPROTECTED BLADE STABBED TECH PRIOR TO THE PROCEDURE (NO GUARD ON THE BLADE). THE KNIFE/BLADE WAS NOT USED IN THE FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658156 SHARPOINT 15 DEG 5.0MM KNIFE EMF SURGICAL SPECIALTIES 72-1551 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other