BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPS® HANDPIECE - UNKNOWN

    MDR report key: 6955500 · Received October 17, 2017

    Report

    Report Number
    1045254-2017-00370
    Event Type
    Malfunction
    Date Received
    October 17, 2017
    Report Date
    December 15, 2017
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    HBE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNKNOWN HANDPIECE HAS NOT BEEN RETURNED FOR EVALUATION. 3318606E (IPC VISAO COOLING SET): THE PRODUCT ANALYSIS INDICATES ONE SAMPLE OF PART NUMBER 3318606E FROM LOT NUMBER 0213624012 WAS RECEIVED. A MICROSCOPE WAS USED TO EVALUATE THE DEVICE. THE VISAO IRRIGATION TUBING SET FOUND THAT WHEN RECEIVED, THE ROLLER CLAMP WAS ENGAGED WHICH CONTROLS THE FLOW OF IRRIGATION THROUGH THE TUBING SET. THE ROLLER CLAMP WAS DISENGAGED FOR THE ANALYSIS. THERE WAS TRACE AMOUNTS OF FLUID IN THE TUBING. VISUALLY, THERE WAS NO DAMAGE OR ANOMALIES IN THE CONSTRUCTION OF THE DEVICE THAT WOULD HAVE RESULTED IN THE REPORTED EVENT. FUNCTIONALLY, WATER PASSED THROUGH BOTH SIDES OF THE TUBING SET UNOBSTRUCTED. THE ENDS WERE BLOCKED OFF AND THE TUBING SET PRESSURIZED WITH NO LEAKS. THERE WAS NO FAULT FOUND THEREFORE MANUFACTURING AND SUPPLIER ISSUES HAVE BEEN RULED OUT AS A LIKELY CAUSE. THE INFORMATION MOST LIKELY INDICATES ONLY A PERCEIVED ISSUE WITH THE DEVICE DUE TO IMPROPER SET UP. CONCLUSION: NO FAILURE DETECTED, DEVICE OPERATED WITHIN SPECIFICATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCT: 3318606E ¿ IPC VISAO COOLING SET, LOT # 0213624012, MANUFACTURED DATE ¿ JUL/10/2017, EXPIRATION DATE ¿ JUL/09/2021, 510(K) # K081277, UDI # (B)(4). EVALUATION WAS NOT PERFORMED ON THE HANDPIECE; THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE IPC VISAO COOLING SET WAS RETURNED FOR ANALYSIS. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE FACILITY REPORTED THAT INTRA-OPERATIVE THE HANDPIECE WAS OVERHEATING DURING DRILLING. THE IPC VISAO IRRIGATION COOLING SET WAS USED ALONG WITH THE HANDPIECE. THE FACILITY CONFIRMED THAT THE WATER IN THE IRRIGATION COOLING SET TUBE DID NOT FLOW. ANOTHER TUBE WAS USED TO COMPLETE THE SURGERY AND THERE WAS NO FURTHER ISSUE. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734472 XPS® HANDPIECE - UNKNOWN DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE MEDTRONIC XOMED INC. XOM UNKNOWN DRILL

    Patients

    Seq Age Sex Outcome Treatment
    1