BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    SHARPOIN T

    MDR report key: 11897698 · Received May 27, 2021

    Report

    Report Number
    3010692967-2021-00018
    Event Type
    Injury
    Date Received
    May 27, 2021
    Date of Event
    April 29, 2021
    Report Date
    May 27, 2021
    Manufacturer
    SURGICAL SPECIALTIES CORPORATION
    Product Code
    GAT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. LOT CODE INFORMATION WAS NOT PROVIDED. THE DETAILS RECEIVED WERE IN REGARDS TO INJURY TO THE NURSE WHEN RETURNING THE DEVICE TO THE PACKAGE. SURGICAL SPECIATIES PRODUCT IS LABELED FOR "ONE TIME" USE. THE KNIFE DEVICES ARE TO BE DISCARDED IN SHARPS CONTAINERS AFTER USE. THERE ARE NO INSTRUCTIONS OR VIDEOS EXPLAINING THE PROCESS OF REPLACING THE PROTECTIVE FOAM COVER OR RETURNING THE DEVICES TO THE ORIGINAL PACKAGES. THE DISTRIBUTOR AND SALES TEAM WERE NOTIFIED OF THE EVENT AND PROVIDED DETAILS OF THE COMPLAINT, LABELING, AND IFU INFORMATION SUPPLIED WITH THE DEVICES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THEY HAD A PROBLEM INVOLVING THE KNIFE USED DURING A CATARACT SURGERY. ONE OF THE NURSE COLLABORATORS HAS BEEN HURT WHEN TRIED TO REPLACE THE KNIFE INSIDE THE PROTECTION (FOAM THAT COMES TO PROTECT THE TIP OF THE MATERIAL) AND INFORMED THAT DAILY THEY LOOSE KNIVES AT THE MOMENT THE PROTECTION FOAM IS REMOVED. ADDITIONAL INFORMATION RECEIVED AND ANSWERS TO QUESTIONS ASKED: 5/7/2021 ADDITIONAL DETAILS RECEIVED FROM THE END USER. THE BLADE INVOLVES IN THIS EVENT IS THE BISTURI OFTALMICO 15 GRAUS RETO DESC. ACO INOX. WERE YOU PROVIDED PHOTOS OF THE DEVICE, INJURY SUSTAINED OR GIVEN THE ITEM AND LOT NUMBER OF THE DEVICE? WE DO NOT HAVE PICTURES FROM THE ACCIDENT; THE HEALTH SAFETY EMPLOYEE OF THE UNIT WAS NOTIFIED AFTER THE OCCURRENCE AND THE MATERIAL HAD ALREADY BEEN DISCARDED. IS IT THE NORMAL PROCESS OF THIS FACILITY TO RETURN THE USED DEVICE TO THE FOAM AND PACKAGE WHEN DISCARDING A USED/ONE TIME USE DEVICE? DURING THE SURGERY, WHERE THE DOCTOR USES THE BLADE MORE THAN ONE TIME IN THE SAME PATIENT, THE ASSISTANTS PLACE THE BLADE INTO THE FOAM SO IT DOES NOT FALL, DOES NOT CONTAMINATE, NEITHER CAUSE ACCIDENT AMONG THE COLLABORATORS. IS THERE A SHARPS CONTAINER AVAILABLE THAT THE DEVICES CAN BE DISCARDED WITHOUT RISKING INJURY WHEN REPLACING THE FOAM TO THE BLADE? YES, THERE IS A BOX IN THE SURGERY ROOM FOR COLLECTION OF SHARPS AND THEY ARE DISCARDED CORRECTLY, ACCORDING TO THE REQUIREMENTS OF THE UNIT¿S PROGRESS. THE CUSTOMER ASKED FOR A TRAINING REGARDING THIS ISSUE; THEY ALSO ASKED HOW TO REMOVE THE MATERIAL CORRECTLY, WITH NO DAMAGE TO THE KNIFE, AND HOW TO STORE IT DURING THE SURGERIES. ON THE SAME DAY, THEY INFORMED THE COLLABORATOR IS WELL AND ITS WAS A LITTLE CUT. ONCE IT WAS AN ACCIDENT, THEY DIDN'T TAKE NOTE OF THE LOT NUMBER OF THE USED KNIFE. THEIR GREATER DOUBT WAS ABOUT RETURNING THE KNIFE TO THE PACKAGE; THEY ASKED IF THIS ACTION IS CORRECT. THEY ALSO SAID IF WE HAVE A VIDEO GIVING DIRECTIONS ON HOW TO MANIPULATE THE KNIFE, IT WOULD BE REALLY HELPFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792752 SHARPOIN T 15 DEG GAT SURGICAL SPECIALTIES CORPORATION UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other