BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARSONNET EPICARDIAL RET

    MDR report key: 10029333 · Received May 6, 2020

    Report

    Report Number
    3011137372-2020-00107
    Event Type
    Malfunction
    Date Received
    May 6, 2020
    Date of Event
    April 8, 2020
    Report Date
    April 8, 2020
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    DWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). THE DEVICE HISTORY RECORD WAS REVIEWED FOR NOTIFICATIONS PERTAINING TO INCOMING INSPECTION, STOCK CHECKS, AND PRODUCT RETURNS. NO CONCERNS WERE NOTED WITH REFERENCE TO (B)(4). (B)(4) SAMPLE OF 342025 WAS RECEIVED FOR EVALUATION. NO VISUAL CONCERNS WERE NOTED. A DIMENSIONAL INSPECTION OF THE SPRING ROD DETERMINED THAT IT WAS ON THE HIGH SIDE OF THE SPECIFICATION @ 1.2MM. THE DEVICE IS WITHIN SPECIFICATION. A HISTORICAL REVIEW OF THIS DEVICE NOTED THAT THE SPRING ROD WAS ORIGINALLY SPECIFIED AS 0.8MM ¿0.2MM THIS WAS INCREASED TO 1.0MM ¿ 0.2MM IN 2014. NO OTHER COMPLAINTS HAVE BEEN RECEIVED IN THAT TIME FRAME. USERS FAMILIAR WITH OR IN POSSESSION OF PRE 2014 DEVICES MIGHT NOTICE AN INCREASE IN SPRING FORCE. ISOLATED INCIDENT. NO OTHER COMPLAINTS HAVE BEEN RECEIVED FOR THIS PRODUCT LINE SINCE THE CHANGES WERE MADE IN 2014. A DIMENSIONAL INSPECTION OF THE SPRING ROD DETERMINED THAT IT WAS ON THE HIGH SIDE OF THE SPECIFICATION @ 1.2MM. THE DEVICE IS WITHIN SPECIFICATION. THE DEVICE FUNCTIONS AS EXPECTED. NO CONFIRMED COMPLAINTS WERE RECEIVED IN THIS RANGE WITH THE SAME ISSUE. SAP WAS REVIEWED FOR NOTIFICATIONS PERTAINING TO INCOMING INSPECTION, STOCK CHECKS, AND PRODUCT RETURNS. NO CONCERNS WERE NOTED WITH REFERENCE TO 342050. A HISTORICAL REVIEW OF THIS DEVICE NOTED THAT THE SPRING ROD WAS ORIGINALLY SPECIFIED AS 0.8MM ¿0.2MM THIS WAS INCREASED TO 1.0MM ¿ 0.2MM IN 2014. NO OTHER COMPLAINTS HAVE BEEN RECEIVED IN THAT TIME FRAME. USERS FAMILIAR WITH OR IN POSSESSION OF PRE 2014 DEVICES MIGHT NOTICE AN INCREASE IN SPRING FORCE. ISOLATED INCIDENT. NO OTHER COMPLAINTS HAVE BEEN RECEIVED FOR THIS PRODUCT LINE SINCE THE CHANGES WERE MADE IN 2014.

    Description of Event or Problem · 0

    THE REPORT STATES: CUSTOMER HAS ALWAYS ORDERED THE EPICARDIAL RETRACTORS FROM TELEFLEX. SURGEONS ARE COMPLAINING THAT THE NEWER ONES ARE TWO STIFF AND NOT SAFE TO USE ON THE HEART. A SURGEON PIERCED THEIR FINGER TRYING TO APPLY THE RETRACTOR. ADDITIONAL INFORMATION REGARDING PIERCED FINGER OF SURGEON: TO MY KNOWLEDGE THIS WAS A MINOR PRICK AND NO TREATMENT WAS REQUIRED ABOVE THE NORMAL WASHING AND DISINFECTING OF THE SITE. TO OUR KNOWLEDGE THE PATIENT HAD NO INFECTIOUS DISEASES.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE INVESTIGATION IS PENDING. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    THE REPORT STATES: CUSTOMER HAS ALWAYS ORDERED THE EPICARDIAL RETRACTORS FROM TELEFLEX. SURGEONS ARE COMPLAINING THAT THE NEWER ONES ARE TWO STIFF AND NOT SAFE TO USE ON THE HEART. A SURGEON PIERCED THEIR FINGER TRYING TO APPLY THE RETRACTOR. ADDITIONAL INFORMATION REGARDING PIERCED FINGER OF SURGEON: TO MY KNOWLEDGE THIS WAS A MINOR PRICK AND NO TREATMENT WAS REQUIRED ABOVE THE NORMAL WASHING AND DISINFECTING OF THE SITE. TO OUR KNOWLEDGE THE PATIENT HAD NO INFECTIOUS DISEASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492374 PARSONNET EPICARDIAL RET INSTRUMENTS, SURGICAL, CARDIOV DWS TELEFLEX MEDICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1