BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KATENA PRODUCTS, INC

    MDR report key: 9497691 · Received December 19, 2019

    Report

    Report Number
    2242450-2019-00002
    Event Type
    Injury
    Date Received
    December 19, 2019
    Date of Event
    November 20, 2019
    Report Date
    December 19, 2019
    Manufacturer
    KATENA PRODUCTS, INC
    Product Code
    HNL
    UDI-DI
    00841668108840
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL AND OPTICAL MICROSCOPY EXAMINATION OF THE RETURNED INSTRUMENT CONFIRMED THAT THE TIP WAS NOT PRESENT AND NOT RETURNED TO THE MANUFACTURER. THE RETURNED INSTRUMENT HAD MANY SCRATCHES AND GOUGES ON THE SURFACES AT THE HOOK AREA. IN ADDITION, MORE SERIOUS DAMAGE OBSERVED WAS THE ROUNDING / FLATTENING OF RIGHT ANGLES AND THE BENT AREA OF THE INNER HOOK GAP ARC WHICH SUGGESTS EXPOSURE TO EXCESSIVE FORCE(S). THESE DAMAGES WERE MOST LIKELY INDUCED BY ENTANGLEMENT WITH OTHER DEVICES DURING TRANSPORTING, CLEANING AND STERILIZATION PROCESSES. THE IFU INCLUDES THE FOLLOWING PERTINENT STATEMENTS, "IT IS VERY IMPORTANT TO CAREFULLY EXAMINE EACH INSTRUMENT FOR BREAKS, CRACKS OR MALFUNCTIONS BEFORE USE. DO NOT USE DAMAGED INSTRUMENTS." REVIEW OF THE MANUFACTURER'S COMPLAINT HANDLING SYSTEM DATABASE CONFIRMED THIS TO BE THE FIRST REPORT OF THIS NATURE FOR THIS DEVICE (K7-2623). THE INSTRUMENT HAS BEEN IN COMMERCIAL DISTRIBUTION FOR SEVERAL YEARS WITHOUT INCIDENT OR COMPLAINT. THE SITE CONTACT INDICATED THAT THERE WAS NO INJURY TO THE PATIENT AND NO PROLONGED HOSPITALIZATION REQUIRED. AN OTOLARYNGOLOGIST EXAMINED THE PATIENT AT A FOLLOW-UP VISIT AND FOUND NO EVIDENCE OF RETAINED METAL, NO FURTHER RECOMMENDATIONS.

    Description of Event or Problem · 1

    AS PROVIDED BY THE SITE: PLASTIC REPAIR OF LEFT CANALICULUS, PROBING DILATION AND SILASTIC TUBE INTUBATION OF THE LEFT NASOLACRIMAL DRAINAGE SYSTEM, EXCISION OF CANALICULAR ABSCESS AND DIVERTICULUM WITH OVER SEWING AND CLOSURE WITH A MICROSCOPE. AFTER A GUIBOR TUBE WAS PASSED, THE TIP OF THE METAL ROD WAS GUIDED OUT WITH THE CRAWFORD RETRIEVAL HOOK. UPON REMOVING THE METAL ROD, THE TIP OF THE CRAWFORD RETRIEVAL HOOK WAS NOTED TO BREAK OFF. ATTEMPTS WERE MADE TO EXTRACT THIS DIRECTLY BUT WERE UNSUCCESSFUL. VISUALIZATION OF THE PIECE WAS MADE WITH A NASAL ENDOSCOPE. THE AREA WAS SUCTIONED NUMEROUS TIMES. THE PIECE WAS NOT RETRIEVED IN THE SUCTION CANISTER TRAP. THE METAL PIECE WAS GONE UPON RE-VISUALIZATION OF THE AREA. PATIENT WAS DISCHARGED HOME AND REFERRED TO AN OTOLARYGOLOGIST FOR FURTHER EVALUATION. FOLLOW-UP VISIT: THE OTOLARYNGOLOGIST HAS SEEN THE PATIENT AND HAS NO FURTHER RECOMMENDATIONS. HE FOUND NO EVIDENCE OF RETAINED METAL DURING HIS EXAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1289336 KATENA PRODUCTS, INC CRAWFORD RETRIEVING HOOK HNL KATENA PRODUCTS, INC K7-2623 NA 00841668108840

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention