BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 14692342 · Received June 15, 2022

    Report

    Report Number
    2955842-2022-12166
    Event Type
    Injury
    Date Received
    June 15, 2022
    Report Date
    May 20, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE ROOT CAUSE OF THE "SLIDING HEM-O-LOK CLIP" RESULTING WITH EMERGENCY UNDOCKING CANNOT BE DETERMINED OR IS UNKNOWN. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. THERE WAS NO IMAGE OR VIDEO CLIP SUPPLIED FOR REVIEW RELATED TO A SPECIFIC EVENT. SYSTEM OR INSTRUMENT LOG REVIEWS COULD NOT BE PERFORMED DUE TO A LACK OF SYSTEM, PROCEDURE, AND INSTRUMENT DETAILS. THE SPECIFIC PROCEDURE/EVENT DATES AND DA VINCI SYSTEM SERIAL #S ARE UNKNOWN. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: WITHIN THE JOURNAL ARTICLE TITLED, ¿ROBOTIC SURGERY IN PEDIATRIC ONCOLOGY: LESSONS LEARNED FROM THE FIRST 100 TUMORS-A NATIONWIDE EXPERIENCE,¿ ONE PATIENT EXPERIENCED AN OPERATIVE COMPLICATION ASSOCIATED WITH A DA VINCI-ASSISTED LEFT NEPHRECTOMY PROCEDURE AND "SLIDING HEM-O-LOK CLIP ON RENAL VEIN" WHICH REQUIRED EMERGENCY UNDOCKING. THE CAUSE OF THE CUSTOMER REPORTED FAILURE MODE IS UNKNOWN. NOTE: REFER TO MEDWATCH REPORT (MDR) WITH PATIENT IDENTIFIER (B)(6) FOR MDR SUBMISSION OF THE OPERATIVE COMPLICATIONS NOTED WITHIN THE ARTICLE THAT ARE NOT ASSOCIATED WITH A REPORTED DEVICE ISSUE.

    Description of Event or Problem · 0

    INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A ANNALS OF SURGICAL ONCOLOGY ARTICLE TITLED, ¿ROBOTIC SURGERY IN PEDIATRIC ONCOLOGY: LESSONS LEARNED FROM THE FIRST 100 TUMORS - A NATIONWIDE EXPERIENCE¿ (BLANC, T., MEIGNAN, P., ET AL., 2022). THE STUDY EVALUATED THE FEASIBILITY AND SAFETY OF ROBOTIC-ASSISTED SURGERY (RAS) IN PEDIATRIC ONCOLOGY, WITH THE AIM OF PROVIDING A NEW SET OF PRACTICAL AND FEASIBLE GUIDELINES FOR PATIENT SELECTION AND TECHNICAL KEY POINTS TO PEDIATRIC SURGEONS. ROBOTIC-ASSISTED TUMOR RESECTIONS WERE PERFORMED BY 7 SENIORS IN 3 DIFFERENT UNIVERSITY CHILDREN'S INSTITUTIONS. BETWEEN 2016 TO 2020, 100 TUMORS WERE RESECTED DURING 93 RAS PROCEDURES INVOLVING 89 CHILDREN. WITHIN THE JOURNAL ARTICLE, OPERATIVE COMPLICATIONS INVOLVING A DA VINCI SURGICAL PROCEDURE WERE NOTED. THERE WERE 7 CONVERSIONS TO OPEN SURGERY. CAUSES FOR CONVERSIONS TO OPEN SURGERY INCLUDED THE FOLLOWING: RENAL VEIN INJURY, MISDIAGNOSED RENAL VEIN TUMOR THROMBUS, POOR RESPIRATORY TOLERANCE AFTER DIAPHRAGMATIC RESECTION, SLIDING HEM-O-LOK CLIP ON RENAL VEIN RESULTING WITH MAJOR BLEEDING (EMERGENCY UNDOCKING), DIFFICULT RENAL HILUM DISSECTION, DIFFICULT DISSECTION (NARROW SPACE), AND DIFFICULT DISSECTION (VASCULAR INVOLVEMENT). 7 PATIENTS RECEIVED INTRA-OPERATIVE TRANSFUSION OF RED BLOOD CELLS. FIVE POSTOPERATIVE SURGICAL COMPLICATIONS WERE REPORTED: 2 PNEUMOTHORAX CASES MANAGED WITH CHEST TUBE PLACEMENT, 1 ANASTOMOTIC STENOSIS CASE MANAGED WITH ENDOSCOPIC BALLOON DILATATION, 1 ADHESIONS CASE MANAGED BY LAPAROTOMY AND ADHESIOLYSIS, AND 1 RETROPERITONEAL COLLECTION CASE MANAGED WITH PERCUTANEOUS DRAINAGE. PER THE ARTICLE, NO SPECIFIC ROBOTIC COMPLICATIONS WERE OBSERVED SUCH AS ADJACENT ORGAN INJURY, POSITIONING RELATED INJURY, OR INJURY DUE TO ROBOTIC ARMS. ISI HAS REACHED OUT TO THE AUTHOR TO OBTAIN ADDITIONAL INFORMATION BUT HAS NOT YET RECEIVED A RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2813532 ENDOWRIST UNKNOWN CLIP APPLIER NAY INTUITIVE SURGICAL, INC N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown DA VINCI INSTRUMENTS AND ACCESSORIES