BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERLED II

    MDR report key: 18534573 · Received January 18, 2024

    Report

    Report Number
    9710055-2024-00051
    Event Type
    Malfunction
    Date Received
    January 18, 2024
    Date of Event
    January 4, 2024
    Report Date
    January 18, 2024
    Manufacturer
    MAQUET SAS
    Product Code
    FTD
    UDI-DI
    3700712412340
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE CORRECTION OF B5 DESCRIBE EVENT AND PROBLEM, D4 CATALOG #, D4 SERIAL #, H3A DEVICE EVALUATED BY MANUFACTURER?, H3B DEVICE NOT EVAL PROVIDE CODE AND H3C IF OTHER PROVIDE CODE -EXPLAIN FIELDS DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS B5 DESCRIBE EVENT AND PROBLEM: ON 11TH JANUARY, 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED II. BASED ON PHOTOGRAPHIC EVIDENCE THE DESIGNATED COMPLAINT UNIT EMPLOYEE FOUND THAT LABEL WAS CHIPPING OFF THE CAMERA (OHD II). THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION OR SERIOUS INJURY. CORRECTED B5 DESCRIBE EVENT AND PROBLEM: ON 11TH JANUARY, 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED II. BASED ON PHOTOGRAPHIC EVIDENCE THE DESIGNATED COMPLAINT UNIT EMPLOYEE FOUND THAT LABEL WAS CHIPPING OFF THE CAMERA (OHD II). THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION OR SERIOUS INJURY. FURTHER INFORMATION PROVIDED BY MANUFACTURER INDICATED THAT DURING SURGERY A STERILIZABLE HANDLE IS PLACED ON AND AROUND THE CAMERA LIKE A "SLEEVE" OR "MUFF", AS A PROTECTION. BASED ON ADDITIONAL INPUT IT WAS POSSIBLE TO DETERMINE THAT THE ISSUE INVESTIGATED HEREIN IS NOT SAFETY AND RISK RELATED, AS THERE WAS NO RISK OF FALLING COMPONENT INTO A PATIENT DURING SURGERY AND POSSIBLE FALL OF THIS SMALL CHIPPING FROM THE LABEL INVOLVED COULD NOT LEAD TO ANY (POTENTIAL) INJURY TO PATIENT, USER OR OTHER PERSON. THEREFORE, THE SCENARIO DESCRIBED IN THE RECORD IS CONSIDERED AS NON-REPORTABLE. PREVIOUS D4 CATALOG # ARDPWT229084A, CORRECTED D4 CATALOG # ARD569204944. PREVIOUS D4 SERIAL # (B)(6), CORRECTED D4 SERIAL # (B)(6). PREVIOUS H3A DEVICE EVALUATED BY MANUFACTURER?: NO. CORRECTED H3A DEVICE EVALUATED BY MANUFACTURER?: YES. PREVIOUS H3B DEVICE NOT EVAL PROVIDE CODE: OTHER. CORRECTED H3B DEVICE NOT EVAL PROVIDE CODE: N/A. PREVIOUS H3C IF OTHER PROVIDE CODE -EXPLAIN: DEVICE NOT RETURNED TO MANUFACTURER. CORRECTED H3C IF OTHER PROVIDE CODE -EXPLAIN: N/A. INITIALLY PROVIDED INFORMATION WAS POINTING TO POTENTIAL FALL OF PARTICLES INTO STERILE FIELD. THE ISSUE IS CONSIDERED AS SAFETY RELATED AS ANY PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION. ACCORDING TO ADDITIONAL INFORMATION PROVIDED BY MANUFACTURER, THE INITIAL INFORMATION WAS NOT CLEAR. IT WAS DETERMINED THAT THE ISSUE INVESTIGATED HEREIN IS NOT SAFETY AND RISK RELATED AS DURING SURGERY A STERILIZABLE HANDLE IS PLACED ON AND AROUND THE CAMERA LIKE A "SLEEVE" OR "MUFF", AS A PROTECTION. CONSEQUENTLY THERE WAS NO RISK OF FALLING COMPONENT INTO A PATIENT DURING SURGERY AND POSSIBLE FALL OF THIS SMALL CHIPPING FROM THE LABEL INVOLVED COULD NOT LEAD TO ANY (POTENTIAL) INJURY TO PATIENT, USER OR OTHER PERSON. THE INVESTIGATION WAS PERFORMED. THE INVESTIGATED SCENARIOS DID NOT CAUSE RISK TO HUMAN LIFE. THE REVIEW OF THE CUSTOMER PRODUCT COMPLAINTS, RELATED TO INVESTIGATED ISSUE IN TIME, SHOWS THAT THERE IS NO REGULAR INCOME. NO APPARENT REASON WAS IDENTIFIED FOR SUGGESTING TO OPEN A CAPA OR EVALUATION FOR THE NEED OF ANOTHER ACTION IN THE MARKET.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 0

    ON 11TH JANUARY, 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED II. BASED ON PHOTOGRAPHIC EVIDENCE THE DESIGNATED COMPLAINT UNIT EMPLOYEE FOUND THAT LABEL WAS CHIPPING OFF THE CAMERA (OHD II). THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION OR SERIOUS INJURY. FURTHER INFORMATION PROVIDED BY MANUFACTURER INDICATED THAT DURING SURGERY A STERILIZABLE HANDLE IS PLACED ON AND AROUND THE CAMERA LIKE A "SLEEVE" OR "MUFF", AS A PROTECTION. BASED ON ADDITIONAL INPUT IT WAS POSSIBLE TO DETERMINE THAT THE ISSUE INVESTIGATED HEREIN IS NOT SAFETY AND RISK RELATED, AS THERE WAS NO RISK OF FALLING COMPONENT INTO A PATIENT DURING SURGERY AND POSSIBLE FALL OF THIS SMALL CHIPPING FROM THE LABEL INVOLVED COULD NOT LEAD TO ANY (POTENTIAL) INJURY TO PATIENT, USER OR OTHER PERSON. THEREFORE, THE SCENARIO DESCRIBED IN THE RECORD IS CONSIDERED AS NON-REPORTABLE.

    Description of Event or Problem · 0

    ON (B)(6) 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED II. BASED ON PHOTOGRAPHIC EVIDENCE THE DESIGNATED COMPLAINT UNIT EMPLOYEE FOUND THAT LABEL WAS CHIPPING OFF THE CAMERA (OHD II). THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852836 POWERLED II LAMP, SURGICAL FTD MAQUET SAS ARDPWT229084A 3700712412340

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown