BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHAPIRO CAPAULE POLISHER

    MDR report key: 16061699 · Received December 28, 2022

    Report

    Report Number
    2242450-2022-00003
    Event Type
    Injury
    Date Received
    December 28, 2022
    Report Date
    December 28, 2022
    Manufacturer
    KATENA PRODUCTS INC.
    Product Code
    HMX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT INSTRUMENT WAS RETURNED TO KATENA FOR EVALUATION ON 14-DEC-2022. MAGNIFIED EVALUATION OF THE SUBJECT INSTRUMENT WAS PERFORMED WITH FOCUS SPECIFICALLY ON THE POLISHING TIP. MULTIPLE ANGLES OF THE SUBJECT TIP WAS EXAMINED USING MULTIPLE MICROSCOPIC MAGNIFICATIONS, YET NO "SHARP PART" ANOMALIES WERE OBSERVED. THE INSTRUMENT WAS GIVEN TO A RESIDENT SUBJECT MATTER EXPERT (SME) FOR SECOND EVALUATION. NO SHARP POINTS WERE VISIBLE DURING MAGNIFIED EVALUATION. INSPECTION DOCUMENTS WERE REVIEWED. NO ISSUE NOTED WITH 5 POSTED TO STOCK. IT HAS BEEN CONCLUDED THAT THE OBSERVED PROTRUSION REPORTED BY THE COMPLAINANT MAY HAVE BEEN FOREIGN MATTER DEBRIS AND NOT A DEFECT ON THE INSTRUMENT. SAID DEBRIS MAY HAVE BEEN REMOVED WHEN THE INSTRUMENT WAS CLEANED FOR SHIPMENT AND THEN FURTHER DECONTAMINATED PRIOR TO KATENA'S EVALUATION. BECAUSE WE COULD NOT CONFIRM THE DEFECT, WE CAN ONLY SPECULATE THAT HARDED FOREIGN MATTER DEBRI COULD POSSIBLY CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE.

    Description of Event or Problem · 0

    ON 29-NOV-2022, A KATENA DISTRIBUTOR IN CHILE REPORTED AN INJURY WHILE A PHYSICIAN WAS USING A K7-4906 SHAPIRO CAPSULE POLISHER DURING A CATARACT SURGERY PROCEDURE. ACCORDING TO THE REPORTER, THE EVENT OCCURED BETWEEN (B)(6) 2022. THE EXACT DATE OF THE EVENT COULD NOT BE OBTAINED. THE REPORTER STATED THAT DURING CAPSULAR POLISHING WITH THE K7-4906, THE POSTERIOR CAPSULE OF THE PATIENT'S EYE WAS TORN. THE SURGEON IMMEDIATELY PERFORMED A VITRECTOMY TO MITIGATE THE EVENT. THE INCIDENT DID NOT NECESSITATE PROLONGED HOSPITALIZATION FOR THE PATIENT. ACCORDING TO THE REPORTER, THE PATIENT'S CURRENT STATUS IS GOOD WITH A GOOD PROGNOSIS FOR RECOVERY. THE DOCTOR ALLEGES THAT THE CAPSULE BREAK WAS CAUSED BY A DEFECT ON THE K7-4906 POLISHER TIP. THE DOCTOR CLAIMS THAT THE INSTRUMENT TIP HAS A "SHARP PART" ON THE TEXTURED TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466620 SHAPIRO CAPAULE POLISHER OPTHALMIC CANNULA HMX KATENA PRODUCTS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention