BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNK

    MDR report key: 7782731 · Received August 14, 2018

    Report

    Report Number
    2027111-2018-00310
    Event Type
    Death
    Date Received
    August 14, 2018
    Date of Event
    July 19, 2018
    Report Date
    September 14, 2018
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GCJ
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT UNIT WAS NOT RETURNED TO APPLIED MEDICAL FOR EVALUATION. AS THE EVENT UNIT WAS NOT RETURNED, TESTING WAS UNABLE TO BE PERFORMED AND THE COMPLAINANT¿S EXPERIENCE COULD NOT BE REPLICATED OR CONFIRMED. APPLIED MEDICAL HAS REVIEWED THE DETAILS SURROUNDING THE EVENT AND RELATED PRODUCTS. AT THIS TIME, APPLIED MEDICAL IS UNABLE TO DETERMINE THE CAUSE OF THE DEATH OR CONFIRM THAT A PRODUCT MALFUNCTION OCCURRED. APPLIED MEDICAL WILL MONITOR ITS VIGILANCE SYSTEMS FOR ANY DEVELOPING TRENDS.

    Additional Manufacturer Narrative · 1

    NO PRODUCT IS BEING RETURNED FOR EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED UPON THE COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    PROCEDURE PERFORMED: DAVINCI UMBILICAL HERNIA REPAIR. DATE OF PROCEDURE: (B)(6) 2018. DATE PATIENT EXPIRED: (B)(6) 2018. INFORMATION RECEIVED VIA PHONE CALL WITH DAVINCI REP ON (B)(6) 2018: STATED THAT A PATIENT HAD EXPIRED. STATED THAT OUR REP, [] WAS PRESENT DURING THE CASE. THERE WAS NO REPORTS OF ANY MALFUNCTION DURING THE CASE. THERE WAS NO OPERATIVE COMPLICATIONS. CASE WAS COMPLETED ROBOTICALLY. THE CASE WAS NOT CONVERTED OR ABORTED. HOWEVER, PATIENT HAD EXPIRED ON (B)(6) 2018. AUTOPSY SHOWED A BOWEL INJURY, BUT NO DETAILS. THE CAUSE OF DEATH IS ASSOCIATED WITH THE BOWEL INJURY BUT CAUSE OF THE BOWEL INJURY IS UNKNOWN. STATED THAT THE 12MM ADV FIXATION OPTICAL TROCAR WAS USED DURING THE CASE. INFORMATION RECEIVED VIA PHONE CALL WITH SALES REP ON (B)(6) 2018: THE SURGEON HAD RECENTLY STARTED DOING ROBOTIC CASES USING THE DAVINCI. THE SURGEON HAS BEEN USING THE CUT DOWN METHOD FOR MANY YEARS. HE RECENTLY RECEIVED COMPLAINTS FROM HIS PATIENTS OF SEVERE PAIN IN THE RUQ. THE REP ADVISED HIM THAT THE PATIENTS OF THE OTHER SURGEONS WERE NOT HAVING THIS ISSUE. THE REP ADVISED HIM THAT MOST SURGEON¿S DO NOT USE THE CUT DOWN APPROACH, BUT INSTEAD WOULD GO IN OPTICALLY WITH THE INSUFFLATION ON. HE AGREED TO TRY THE METHOD OUT IN THE NEXT CASE TO SEE IF IT WOULD MAKE A DIFFERENCE. THE INTUITIVE REP AND APPLIED REP WERE PRESENT DURING THE CASE. REP STATED THAT IT WAS THE 12MM OPTICAL Z THREAD BEING USED AND NOT THE ADV FIXATION. THERE WERE NO ISSUES USING THE METHOD DURING THE CASE. IT WAS COMPLETED WITHOUT ANY INJURY. THE SURGEON WANTED TO CONTINUE USING THE TECHNIQUE IN HIS FOLLOWING PROCEDURES. SHE ADVISED HIM ON THE SETTINGS OF THE INSUFFLATION AND TO GO IN MORE PERPENDICULARLY BECAUSE HE WENT IN AT AN ANGLE AND MAY HAVE CUT THE FASCIA. SHE ADVISED TO PULL UP ON THE SKIN.

    Description of Event or Problem · 1

    PROCEDURE PERFORMED: DAVINCI UMBILICAL HERNIA REPAIR. DATE OF PROCEDURE: (B)(6) 2018. DATE PATIENT EXPIRED: (B)(6) 2018. INFORMATION RECEIVED VIA PHONE CALL WITH DAVINCI REP ON JULY 25, 2018: STATED THAT A PATIENT HAD EXPIRED. STATED THAT OUR REP, WAS PRESENT DURING THE CASE. THERE WAS NO REPORTS OF ANY MALFUNCTION DURING THE CASE. THERE WAS NO OPERATIVE COMPLICATIONS. CASE WAS COMPLETED ROBOTICALLY. THE CASE WAS NOT CONVERTED OR ABORTED. HOWEVER, PATIENT HAD EXPIRED ON (B)(6) 2018. AUTOPSY SHOWED A BOWEL INJURY, BUT NO DETAILS. THE CAUSE OF DEATH IS ASSOCIATED WITH THE BOWEL INJURY BUT CAUSE OF THE BOWEL INJURY IS UNKNOWN. STATED THAT THE 12MM ADV FIXATION OPTICAL TROCAR WAS USED DURING THE CASE. INFORMATION RECEIVED VIA PHONE CALL WITH SALES REP ON JULY 25, 2018: THE SURGEON HAD RECENTLY STARTED DOING ROBOTIC CASES USING THE DAVINCI. THE SURGEON HAS BEEN USING THE CUT DOWN METHOD FOR MANY YEARS. HE RECENTLY RECEIVED COMPLAINTS FROM HIS PATIENTS OF SEVERE PAIN IN THE RUQ. THE REP ADVISED HIM THAT THE PATIENTS OF THE OTHER SURGEONS WERE NOT HAVING THIS ISSUE. THE REP ADVISED HIM THAT MOST SURGEON¿S DO NOT USE THE CUT DOWN APPROACH, BUT INSTEAD WOULD GO IN OPTICALLY WITH THE INSUFFLATION ON. HE AGREED TO TRY THE METHOD OUT IN THE NEXT CASE TO SEE IF IT WOULD MAKE A DIFFERENCE. THE INTUITIVE REP AND APPLIED REP WERE PRESENT DURING THE CASE. REP STATED THAT IT WAS THE 12MM OPTICAL Z THREAD BEING USED AND NOT THE ADV FIXATION. THERE WERE NO ISSUES USING THE METHOD DURING THE CASE. IT WAS COMPLETED WITHOUT ANY INJURY. THE SURGEON WANTED TO CONTINUE USING THE TECHNIQUE IN HIS FOLLOWING PROCEDURES. SHE ADVISED HIM ON THE SETTINGS OF THE INSUFFLATION AND TO GO IN MORE PERPENDICULARLY BECAUSE HE WENT IN AT AN ANGLE AND MAY HAVE CUT THE FASCIA. SHE ADVISED TO PULL UP ON THE SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624229 UNK GCJ GCJ APPLIED MEDICAL RESOURCES UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death