BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUN MED

    MDR report key: 22038624 · Received May 16, 2025

    Report

    Report Number
    1314417-2025-00027
    Event Type
    Malfunction
    Date Received
    May 16, 2025
    Date of Event
    April 2, 2025
    Report Date
    August 21, 2025
    Manufacturer
    SUNMED HOLDINGS LLC
    Product Code
    CCW
    UDI-DI
    10889483003060
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: (APPROPRIATE TERM/CODE NOT AVAILABLE) G: DEVICE HANDLE. THE PRODUCT INVOLVED IN THE REPORT HAS NOT BEEN RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. THE DOCUMENTED UDI IS BASED ON THE STOCK/PRODUCT CODE PROVIDED BY THE REPORTER; THE UDI-PI IS NOT AVAILABLE AS NO LOT NUMBER WAS PROVIDED. ALL INFORMATION REASONABLY KNOWN AS OF 16 MAY 2025 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY SUN MED HOLDINGS LLC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO SUN MED HOLDINGS LLC. SUN MED HOLDINGS LLC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE SUN MED HOLDINGS COMPLAINT DATABASE AND IDENTIFIED AS (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21 CFR 803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN SUN MED HOLDINGS LLC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    H6: (APPROPRIATE TERM/CODE NOT AVAILABLE) G: DEVICE HANDLE. H6: (APPROPRIATE TERM/CODE NOT AVAILABLE) D: INTERNAL SHORT. CORRECTION: D9. ADDITIONAL INFORMATION-INVESTIGATION CONCLUSION: H6. THE PRODUCT INVOLVED IN THE REPORT WAS RETURNED FOR EVALUATION. FUNCTIONAL TESTING, PERFORMED BY THE SUPPLIER REVEALED: THE BULB TURNED ON BRIEFLY AND IMMEDIATELY BECAME HOT, AN INDICATION OF A POTENTIAL INTERNAL SHORT CIRCUIT. THE REPORTED ISSUE WAS CONFIRMED. TO VALIDATE THE ASSUMPTION, BULB WAS REPLACED AND THE BLADE ON THE HANDLE WAS ENGAGED AND KEPT IT ON FOR 15 MINUTES; DURING THIS PERIOD, THE HANDLE REMAINED FULLY FUNCTIONAL WITH NO SIGNS OF OVERHEATING. THE ROOT CAUSE WAS DETERMINED TO BE AN INTERNAL SHORT CIRCUIT IN THE BULB, WHICH RESULTED IN ABNORMAL HEATING AND FAILURE TO ILLUMINATE; REPLACING THE BULB RESOLVED THE ISSUE COMPLETELY. THE DEVICE HISTORY RECORD (DHR) REVIEW FOUND NO ABNORMAL PROCESSING ISSUES; ALL PRODUCTS/PACKAGING WERE PRODUCED PER THE APPROVED MANUFACTURING PROCEDURES, SPECIFICATIONS, AND INSPECTIONS. THE DOCUMENTED UDI IS BASED ON THE STOCK/PRODUCT CODE PROVIDED BY THE REPORTER; THE UDI-PI IS NOT AVAILABLE AS NO LOT NUMBER WAS PROVIDED. ALL INFORMATION REASONABLY KNOWN AS OF 21 AUG 2025 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY SUN MED HOLDINGS LLC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO SUN MED HOLDINGS LLC. SUN MED HOLDINGS LLC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE SUN MED HOLDINGS COMPLAINT DATABASE AND IDENTIFIED AS (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN SUN MED HOLDINGS LLC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED, THE CUSTOMER PUT THE BLADE IN IT AND THE PRODUCT [BECAME] SO HOT THEY COULD NOT HOLD ONTO IT ANYMORE. THERE WAS NO REPORT OF MEDICAL INTERVENTION.

    Description of Event or Problem · 0

    IT WAS REPORTED, THE CUSTOMER PUT THE BLADE IN IT AND THE PRODUCT [BECAME] SO HOT THEY COULD NOT HOLD ONTO IT ANYMORE. THERE WAS NO REPORT OF MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98934 SUN MED GREENLINE C/P LARGE HANDLE D CCW SUNMED HOLDINGS LLC 5-0236-15 UNKNOWN 10889483003060

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown