BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CB030, 5MMX35CM EPIX LAPA SCISSOR, 10/BX

    MDR report key: 13968303 · Received March 31, 2022

    Report

    Report Number
    2027111-2022-00538
    Event Type
    Malfunction
    Date Received
    March 31, 2022
    Date of Event
    March 15, 2022
    Report Date
    June 20, 2022
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    HET
    UDI-DI
    00607915110123
    PMA / PMN Number
    K062169
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT UNIT WAS RETURNED TO APPLIED MEDICAL FOR EVALUATION. TESTING WAS PERFORMED ON THE RETURNED UNIT, WHERE NO COAGULATION WAS OBSERVED AWAY FROM THE SCISSOR BLADES. THEREFORE, THE COMPLAINANT¿S EXPERIENCE OF ARCING TO NON-TARGET TISSUE COULD NOT BE CONFIRMED. APPLIED MEDICAL HAS REVIEWED THE DETAILS SURROUNDING THE EVENT AND RELATED PRODUCTS AND IS UNABLE TO DETERMINE THE CAUSE OF THE REPORTED EVENT BASED ON THE EVALUATION OF THE RETURNED UNIT. THE PROBABILITY AND CRITICALITY OF HARM RESULTING FROM THIS FAILURE HAVE BEEN EVALUATED AND WERE FOUND TO BE AT AN ACCEPTABLE LEVEL. CORRECTION: SECTION H6 (COMPONENT CODE) IS BEING UPDATED TO MORE ACCURATELY REFLECT THE COMPONENT OF THE DEVICE THAT WAS ALLEGED TO MALFUNCTION BY THE USER FACILITY.

    Additional Manufacturer Narrative · 0

    THE EVENT DEVICE IS ANTICIPATED TO BE RETURNED TO APPLIED MEDICAL FOR EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: INGUINAL HERNIA. EVENT DESCRIPTION: SCISSOR COAGULATED AT THE LEVEL OF GREEN COATING NOT AT THE LEVEL OF THE SCISSOR. THEY TOOK ANOTHER SCISSOR AND FINISHED THE PROCEDURE WITHOUT PROBLEM PATIENT OK! CUSTOMER EMAIL: IK HEB NET EEN SCHAAR TERUG GEKREGEN DIE COAGULEERT TER HOOGTE VAN DE GROENE COATING (WAAR LABEL VAN FIRMA STAAT) EN NIET TER HOOGTE VAN HET SCHAAR GEDEELTE. DIT GEEFT ZEER GEVAARLIJKE SITUATIES. EPIX SCHAAR CB030 (LOT 1443223). [TRANSLATION]: I JUST RECEIVED A SCISSOR BACK THAT COAGULATES AT THE LEVEL OF THE GREEN COATING (WHERE THE LOGO OF THE COMPANY IS) AND NOT AT THE SCISSOR SECTION. THIS CAUSES DANGEROUS SITUATIONS. EPIX SCISSORS CB030 (LOT 1443223). ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 21-MAR-2022: THE UNIT WAS PUT ASIDE, BUT TODAY THEY WERE NOT ABLE TO LOCATE IT TO BE RETURNED FOR THE INVESTIGATION. THE TERRITORY MANAGER IS TRYING TO LOCATE IT, ALTERNATIVELY THEY POTENTIALLY HAVE FOOTAGE OF THE INCIDENT. HE DESCRIBED IT AS COAGULATION OF CONNECTIVE TISSUE 5CM INTO THE ISOLATION OF THE SCISSORS. LUCKILY IT WAS ONLY CONNECTIVE TISSUE, BUT THEY WERE VERY WORRIED IN CASE IT WOULD HAPPEN IN ANOTHER PROCEDURE AND FOR EXAMPLE ACCIDENTLY PUNCTURE THE COLON WITHOUT NOTICING. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 25-MAR-2022: THE INCIDENT HAPPENED DURING AN INGUINAL HERNIA REPAIR. THE PATIENT WAS NOT HURT. A NEW PAIR OF SCISSORS WAS TAKEN AND THE PROCEDURE WAS COMPLETED. THE DEVICE HAS BEEN LOCATED AND WILL BE RETURNED. INTERVENTION: CHANGE OF DEVICE. PATIENT STATUS: PATIENT OK.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: INGUINAL HERNIA. EVENT DESCRIPTION: SCISSOR COAGULATED AT THE LEVEL OF GREEN COATING NOT AT THE LEVEL OF THE SCISSOR. THEY TOOK ANOTHER SCISSOR AND FINISHED THE PROCEDURE WITHOUT PROBLEM PATIENT OK!. [TRANSLATION]: I JUST RECEIVED A SCISSOR BACK THAT COAGULATES AT THE LEVEL OF THE GREEN COATING (WHERE THE LOGO OF THE COMPANY IS) AND NOT AT THE SCISSOR SECTION. THIS CAUSES DANGEROUS SITUATIONS. EPIX SCISSORS CB030 (LOT 1443223). ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 21-MAR-2022: THE UNIT WAS PUT ASIDE, BUT TODAY THEY WERE NOT ABLE TO LOCATE IT TO BE RETURNED FOR THE INVESTIGATION. THE TERRITORY MANAGER IS TRYING TO LOCATE IT, ALTERNATIVELY THEY POTENTIALLY HAVE FOOTAGE OF THE INCIDENT. HE DESCRIBED IT AS COAGULATION OF CONNECTIVE TISSUE 5CM INTO THE ISOLATION OF THE SCISSORS. LUCKILY IT WAS ONLY CONNECTIVE TISSUE, BUT THEY WERE VERY WORRIED IN CASE IT WOULD HAPPEN IN ANOTHER PROCEDURE AND FOR EXAMPLE ACCIDENTLY PUNCTURE THE COLON WITHOUT NOTICING. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 25-MAR-2022: THE INCIDENT HAPPENED DURING AN INGUINAL HERNIA REPAIR. THE PATIENT WAS NOT HURT. A NEW PAIR OF SCISSORS WAS TAKEN AND THE PROCEDURE WAS COMPLETED. THE DEVICE HAS BEEN LOCATED AND WILL BE RETURNED. INTERVENTION: CHANGE OF DEVICE. PATIENT STATUS: PATIENT OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2190170 CB030, 5MMX35CM EPIX LAPA SCISSOR, 10/BX LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES) HET APPLIED MEDICAL RESOURCES CB030 1443223 00607915110123

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown