BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EEA

    MDR report key: 20141182 · Received September 4, 2024

    Report

    Report Number
    2647580-2024-03854
    Event Type
    Injury
    Date Received
    September 4, 2024
    Date of Event
    June 14, 2024
    Report Date
    September 4, 2024
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GDW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    JAROSLAV PRESL, "ROBOTIC SURGERY VERSUS CONVENTIONAL LAPAROSCOPY IN SIGMOID COLECTOMY FOR DIVERTICULAR DISEASE-A COMPARISON OF OPERATIVE TRAUMA AND COST-EFFECTIVENESS: RETROSPECTIVE, SINGLE-CENTER ANALYSIS", 2024, LANGENBECK'S ARCHIVES OF SURGERY (2024) 409:200 MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    CORRECTION: LITERATURE FILE UPLOADED MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE, A RETROSPECTIVE STUDY COMPARED ELECTIVE LAPAROSCOPIC AND ROBOTIC OUTCOMES IN PATIENTS WHO UNDERWENT ELECTIVE MINIMALLY INVASIVE LEFT SIDED COLECTOMY FOR DIVERTICULAR DISEASE BETWEEN JANUARY 2016 AND DECEMBER 2020. IN TOTAL, 83 PATIENTS WERE INCLUDED, OF WHICH 42 UNDERWENT CONVENTIONAL LAPAROSCOPIC SURGERY AND 41 ROBOTIC ASSISTED SURGERY. IN BOTH GROUPS, AN END-TO-END INTRACORPOREAL ANASTOMOSIS WITH A CIRCULAR 28 MM EEA CIRCULAR STAPLER WAS PERFORMED. THE RESECTED BOWEL SEGMENT WAS RETRIEVED EXCLUSIVELY VIA PFANNENSTIEL INCISION IN ALL CASES. POSTOPERATIVE COMPLICATIONS INCLUDED BLEEDING WHICH REQUIRED OPERATIVE TREATMENT AND EXTENDED HOSPITAL STAY. OTHER COMPLICATIONS NOT RELATED TO THE DEVICE INCLUDED: SEROMA, INFECTION, SUPRAPUBIC BLEEDING AND ABSCESS, NEUROLOGICAL IRRITATION, AND HIGH BLOOD PRESSURE. ROBOTIC SURGERY VERSUS CONVENTIONAL LAPAROSCOPY IN SIGMOID COLECTOMY FOR DIVERTICULAR DISEASE-A COMPARISON OF OPERATIVE TRAUMA AND C OST-EFFECTIVENESS: RETROSPECTIVE, SINGLE-CENTER ANALYSIS JAROSLAV PRESL1 LANGENBECK'S ARCHIVES OF SURGERY (2024) 409:200 HTTPS://DOI.ORG/10.1007/S00423-024-03382-0

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1186409 UNKNOWN EEA STAPLE, IMPLANTABLE GDW US SURGICAL PUERTO RICO UNKNOWN EEA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization