BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST STAPLER 45 RELOAD,BLUE

    MDR report key: 5170423 · Received October 23, 2015

    Report

    Report Number
    2955842-2015-01320
    Event Type
    Malfunction
    Date Received
    October 23, 2015
    Date of Event
    September 28, 2015
    Report Date
    September 28, 2015
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K140553
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL, INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE FOR THE REPORTED FAILURE MODE. THE INSTRUMENT STAPLER 45 BLUE RELOAD HAS NOT BEEN RETURNED FOR EVALUATION. ISI HAS REVIEWED THE SYSTEM LOGS FOR THE SITE WITH A PROCEDURE DATE OF (B)(6) 2015. IT SHOWED THAT THE STAPLER 45 INSTRUMENT FIRED 4 BLUE RELOADS AND WERE COMPLETED SUCCESSFULLY, PEAK FIRE TORQUES WERE BETWEEN 33 AND 35 MNM. HOWEVER SYSTEM LOGS DO NOT PREDICT POOR STAPLE FORMATION. THE SAME STAPLER INSTRUMENT WAS USED AGAIN ON (B)(6) 2015 AND FIRED ONE GREEN RELOAD WITH NO ISSUES. AT THIS TIME, IT IS UNKNOWN WHAT CAUSED OR CONTRIBUTED TO THE ENDOWRIST STAPLER 45 RELOAD, BLUE, TO HAVE MALFORMED STAPLES. THERE IS NO INDICATION THAT THE PATIENT EXPERIENCED A SERIOUS INJURY BECAUSE OF THE REPORTED ISSUE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE COMPLAINT WILL BERE-EVALUATED.

    Additional Manufacturer Narrative · 1

    COMMON DEVICE NAME: PREVIOUSLY REPORTED 'ENDOSCOPIC ELECTROSURGICAL ACCESSORY' WAS CORRECTED TO 'ENDOSCOPIC INSTRUMENT ACCESSORY'.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI HEMICOLECTOMY PROCEDURE, THE SURGEON FOUND MALFORMED STAPLES AFTER PERFORMING A CLAMP AND CUT FUNCTION WITH THE STAPLER 45 INSTRUMENT WITH THE STAPLER 45 BLUE RELOAD. DURING THE RESECTION OF THE LUMEN AND INSPECTION OF A STAPLER LINE, THE SURGEON FOUND STAPLES THAT WERE NOT IN A GOOD B-FORMATION STICKING OUT FROM THE OUTSIDE OF THE BOWEL. PER THE REPORTER, THE SURGEON DID NOT INTERVENE FURTHER AS HE FELT THE TISSUE WAS ADEQUATELY STAPLED. THERE WAS NO TISSUE INJURY, LEAK OR BLEEDING. THE BOWEL WAS NOT TOO THICK AND THERE WAS NO TISSUE BUNCHING. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED. ON (B)(6) 2015, THE INITIAL REPORTER INDICATED THAT THE CUSTOMER HAS USED THE STAPLER 45 INSTRUMENT INVOLVED WITH THIS EVENT HAS BEEN USED IN SUBSEQUENT SURGICAL PROCEDURES AND HAD NO REPORTED ISSUES. THE CUSTOMER DISCARDED THE STAPLER 45 BLUE RELOAD WITH THE REPORTED MALFORMED STAPLES AND WILL NOT BE ABLE TO RETURN TO INTUITIVE SURGICAL, INC. FOR FURTHER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701342 ENDOWRIST STAPLER 45 RELOAD,BLUE ENDOSCOPIC INSTRUMENT ACCESSORY NAY INTUITIVE SURGICAL,INC. 48645B

    Patients

    Seq Age Sex Outcome Treatment
    1