BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HNM SCISSORS

    MDR report key: 7594106 · Received June 12, 2018

    Report

    Report Number
    3005031118-2018-00002
    Event Type
    Malfunction
    Date Received
    June 12, 2018
    Report Date
    June 11, 2018
    Manufacturer
    HNM STAINLESS, LLC DBA HNM MEDICAL
    Product Code
    LRW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT WAS REPORTED TO HNM ON MARCH 12, 2018. HNM ORIGINALLY REVIEWED THIS COMPLAINT AND DETERMINED THAT IT WAS NOT A REPORTABLE EVENT DUE TO THE FACT THAT THERE WAS NO PATIENT SERIOUS INJURY OR DEATH DUE TO THE FAILURE. DURING A FDA AUDIT ON APRIL 30 - MAY 9, 2018, THE FDA REVIEWED THIS COMPLAINT AND FOUND THAT THE MDR DECISION TREE BUT DOES NOT INCLUDE ADEQUATE EVALUATION AND JUSTIFICATION TO SHOW THAT THIS WAS NOT AN MDR REPORTABLE EVENT AND THAT CORRECTIVE AND PREVENTIVE ACTION (CAPA) WAS NOT REQUIRED. DUE TO THIS, THE COMPLAINT WAS RE-EVALUATED AND IT HAS BEEN DECIDED THAT AN MDR IS REQUIRED SINCE THIS COMPLAINT REQUIRED THE SURGERY TO EXTEND THIRTY EXTRA MINUTES FOR THE SURGEON TO LOCATE AND REMOVE THE BROKEN SCISSOR FROM THE ABDOMINAL CAVITY.

    Description of Event or Problem · 1

    HNM MEDICAL SCISSOR (CAT # HNM-1-32-750) BROKE DURING ABDOMINAL SURGERY. THE SURGEON WAS CUTTING THE PERITONEUM AND HANDED THEM BACK TO THE SCRUB TECH THAT NOTICED A PIECE OF THE SCISSORS WERE MISSING. THE PATIENT WAS ALREADY OPEN AND NO FURTHER CUTS WERE MADE, BUT THE SURGEON AND TECH GENTLY SEARCHED THE PATIENT AND AFTER ABOUT 30 MIN FOUND THE MISSING SCISSOR PIECE LAYING ON TOP TO THE INTESTINES. NO CLINICAL COMPLICATIONS, JUST PROLONGED STAY AND ANESTHESIA. PATIENT IS CURRENTLY STABLE AND WAS NOT OBSERVED TO SUFFER ANY MAJOR COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436570 HNM SCISSORS SCISSORS, GENERAL, SURGICAL LRW HNM STAINLESS, LLC DBA HNM MEDICAL HNM-1-32-750

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization