BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO PADDLE RETRACT

    MDR report key: 18813208 · Received February 29, 2024

    Report

    Report Number
    2647580-2024-01044
    Event Type
    Malfunction
    Date Received
    February 29, 2024
    Date of Event
    February 12, 2024
    Report Date
    May 21, 2024
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GAD
    UDI-DI
    10884523000771
    PMA / PMN Number
    K914190
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT PRODUCTS: 173046, 173046 ENDO PADDLE RETRACTOR X3 (LOT#:P3H1069). MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. VISUAL INSPECTION NOTED THE PADDLE COVER OF THE DEVICE WAS DISENGAGED AND NOT RECEIVED. FUNCTIONALLY, THE PADDLE FULLY CLOSED AND OPENED BY TURNING OF BLACK ROTATION KNOB. THE DEVICE WAS ABLE TO BE RETRACTED. IT WAS REPORTED THAT THE DEVICE BROKE OFF. THE REPORTED ISSUE WAS CONFIRMED. THE PRODUCT ANALYSIS NOTED EVIDENCE THAT THE DEVICE WAS NOT USED AS INTENDED. THIS ISSUE MAY OCCUR WHEN EITHER THE PADDLE RETRACTOR IS RETRACTED WITH THE PADDLE IN A PARTIALLY OPEN STATE; PUSHING THE INTRODUCER FORWARD OVER A PADDLE THAT IS NOT FULLY CLOSED MAY CAUSE STRETCHING AND BREAKAGE OF THE INTRODUCER; OR IF THE PADDLE RETRACTOR IS SUBJECTED TO EXCESSIVE MANIPULATION OR USED FOR LEVERAGE, THESE FORCES MAY CAUSE THE TEARING OF THE COVER/ CLOTH. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. THE INSTRUCTIONS INCLUDED WITH THIS DEVICE PROVIDE THE FOLLOWING GUIDANCE: DEVICE IS CONTRAINDICATED FOR CERTAIN APPLICATION. DEVICE IS TO BE DISPOSED OF PROPERLY. PRODUCT SALE AND USE IS RESTRICTED TO SURGEONS AND QUALIFIED INDIVIDUALS. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, BEFORE A LAPAROSCOPIC BARIATRIC PROCEDURE, WHEN THE USER OPENED THE THREE DEVICES, IT WAS BENT. DURING THE PROCEDURE, WHILE INSERTING A NEW DEVICE, THE DEVICE BROKE OFF. NO COMPONENT FALL INTO THE CAVITY OF THE PATIENT. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290488 ENDO PADDLE RETRACT RETRACTOR GAD US SURGICAL PUERTO RICO 173046 P3H1069 10884523000771

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown