BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNI HYSTEROSCOPIC SCISSORS

    MDR report key: 23569788 · Received November 17, 2025

    Report

    Report Number
    1222780-2025-00580
    Event Type
    Malfunction
    Date Received
    November 17, 2025
    Date of Event
    November 4, 2025
    Report Date
    January 9, 2026
    Manufacturer
    HOLOGIC, INC
    Product Code
    NWW
    UDI-DI
    15420045515529
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION WAS CLOSED ON DECEMBER 23RD 2025.

    Additional Manufacturer Narrative · 0

    HOLOGIC PERFORMED AN INVESTIGATION RELATED TO THE 3 DEVICES USED DURING THE PROCEDURE. DURING A MEDICAL PROCEDURE, THREE HOLOGIC PRODUCTS WERE USED: THE MYOSURE LITE DEVICE FOR RESECTING POLYPLOID TISSUE, OMNI SCISSORS FOR REMOVING UTERINE SCARRING, AND THE HYSTEROSCOPE FOR IMAGING. FOLLOWING THE PROCEDURE, A LONG STRAND OF APPARENT METAL WAS OBSERVED IN THE PATIENT¿S UTERINE CAVITY. THE FOREIGN OBJECT WAS APPARENTLY SUCCESSFULLY REMOVED WITH GRASPERS BY THE ATTENDING PHYSICIAN WITHOUT INCIDENT OR REPORTED PATIENT INJURY. THE PATIENT SUBSEQUENTLY UNDERWENT AN X-RAY WHICH DID NOT REVEAL PIECES INSIDE. THE INVESTIGATION CONTEMPLATED THE 3 DEVICES USED IN THE PATIENT: THE INVESTIGATION RELATED TO THE MYOSURE LITE DEVICE WAS UNABLE TO REPRODUCE THE REPORTED ISSUE BUT IDENTIFIED METAL SHAVINGS. NO DIRECT EVIDENCE LINKED THE MYOSURE LITE DEVICE TO THE REPORTED APPARENT METAL STRAND. THE INVESTIGATION RELATED TO THE HYSTEROSCOPE REVEALED MULTIPLE DAMAGE CONSISTENT WITH USER HANDLING (OUTER TUBE DENTS, DISTAL TIP DAMAGE, SCRATCHES, FIBER DAMAGE, PARTICULATE UNDER LENSES, ADHESIVE RESIDUES). POTENTIAL FOR INTERNAL SCRATCHING FROM PASSING BENT SCISSORS NOTED, BUT NO EVIDENCE AVAILABLE TO CONFIRM SCRATCHES OF SUFFICIENT DEPTH OR WEAR TO PRODUCE A LONG METAL STRAND. THE INVESTIGATION RELATED TO THE OMNI SCISSORS REVEALED THE TIP OF THE BLADE WAS BENT. UNDER MAGNIFICATION, EXCESSIVE FRICTION FROM MISALIGNED, COLLIDING BLADES RESULTED IN METALLIC WORN BUT NOT CAPABLE OF PRODUCING LONG STRANDS OF METAL. THIN THREADS WERE OBSERVED IN SEVERAL PLACES OF THE BLADES, THIS FIBER WAS SIMILAR TO THE FIBER OBSERVED IN THE PATIENT. FIBERS WERE TAKEN FROM THE BLADES TO BE SUBJECT OF A MATERIAL CHARACTERIZATION TO DETERMINE THE CHEMICAL COMPOSITION. THE PHYSICAL-CHEMICAL ANALYSIS REPORT CONCLUDED THAT THE FIBER FOUND ON THE OMNI SCISSORS DEVICE TIP IS COMPOSED OF MATERIAL REMOVED FROM THE TIP PROTECTOR, WHICH IS MADE OF TPE (THERMOPLASTIC ELASTOMER). A MORE IN-DEPTH INVESTIGATION CONCLUDED THAT THE GENERATION OF THE TPE FIBERS INSIDE THE SCISSOR TIP PROTECTOR OCCURS DUE TO THE MECHANICAL INTERACTION BETWEEN THE SHARP SCISSOR BLADES AND THE PROTECTOR´S INTERNAL SURFACE. FIBERS COSMETICALLY LIKE THE REPORTED FOREIGN BODY WERE OBSERVED ON THE BLADES OF THE OMNI SCISSOR. IT WAS CONFIRMED THAT FIBERS ARE COMPOSED OF TPE FROM THE BLADE¿S PROTECTOR. THE INVESTIGATION WAS UNABLE TO CONCLUSIVELY LINK THE FOREIGN OBJECT FOUND IN THE PATIENT TO THE OMNI SCISSORS AS THE OBJECT WAS NOT RETURNED. THE CONCLUSION FROM THE INVESTIGATION WAS THE MYOSURE LITE AND HYSTEROSCOPE WERE NOT FOUND TO BE DIRECTLY RESPONSIBLE BASED ON CURRENT EVIDENCE AND THAT THE OMNI SCISSORS DEMONSTRATED EVIDENCE OF PLASTIC FIBERS DETACHMENT FROM THE TIP PROTECTOR BUT THE OBJECT REPORTED BY THE CUSTOMER WAS NOT RETURNED WHICH RESULTED IN THE INVESTIGATION BEING INCONCLUSIVE OF THE ORIGIN OF THE FOREIGN OBJECT OBSERVED.

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE REPORTED LOT/SERIAL NUMBER. THE DEVICE WAS RELEASED MEETING ALL QA SPECIFICATIONS. THE DEVICE INVOLVED IN THIS EVENT WAS NOT RETURNED FOR EVALUATION PURPOSES THEREFORE VISUAL AND FUNCTIONAL ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED. WE ARE UNABLE TO CONFIRM A RELATIONSHIP BETWEEN THE DEVICE AND THE ISSUE REPORTED. THE INFORMATION OBTAINED DURING COMPLAINT INVESTIGATION WILL BE INCLUDED IN OUR GLOBAL COMPLAINT TRENDING AND PRODUCT SURVEILLANCE WILL CONTINUE TO MONITOR COMPLAINTS OF THIS TYPE FOR ADVERSE TRENDS. IF THE PRODUCT IS RECEIVED OR ADDITIONAL INFORMATION IS OBTAINED, THE INVESTIGATION WILL BE REOPENED ACCORDINGLY PER STANDARD OPERATING PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A MYOSURE PROCEDURE ON (B)(6) 2025, THE PHYSICIAN USED THE MYOSURE LITE DEVICE TO RESECT SOME POLYPOID TISSUE AND THE OMNI SCISSORS TO HELP TAKE DOWN SOME SCARRING IN THE PATIENT'S UTERUS. WHEN THE PHYSICIAN WENT BACK IN TO TAKE FINAL PICTURES, A LONG STRAND OF METAL IN THE PATIENT'S CAVITY WAS NOTED. THE PHYSICIAN REMOVED THE SHAVINGS USING THE GRASPERS. THERE WAS NO HARM REPORTED. AN X RAY WAS PERFORMED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2872980 OMNI HYSTEROSCOPIC SCISSORS HYSTEROSCOPE ACCESSORIES NWW HOLOGIC, INC OMNI-S-001 24F25RF 15420045515529

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown