BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EEA

    MDR report key: 20964510 · Received December 18, 2024

    Report

    Report Number
    2647580-2024-05180
    Event Type
    Injury
    Date Received
    December 18, 2024
    Date of Event
    August 19, 2024
    Report Date
    December 18, 2024
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCTS: UNKNOWN EEA UNKNOWN EEA - (LOT#UNKNOWN). 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 SHORT-TERM POSTOPERATIVE OUTCOMES BETWEEN POWERED AND MANUAL CIRCULAR STAPLERS IN COLORECTAL CANCER PATIENTS BETWEEN (B)(6) 2023. THERE WERE 511 PATIENTS IN THE STUDY, WITH A COMPETITOR-POWERED STAPLER USED IN 161 AND A MANUAL STAPLER USED IN 345 PATIENTS. IN THE MANUAL STAPLER GROUP, THE MEDTRONIC CEEA STAPLER WAS USED IN 182 PATIENTS, AND THE DST WAS USED IN 23 PATIENTS. POSTOPERATIVE COMPLICATIONS IN THE MANUAL GROUP INCLUDED ANASTOMOTIC LEAK IN SEVEN PATIENTS, ANASTOMOTIC BLEEDING IN ONE PATIENT, SURGICAL SITE INFECTION IN 17 PATIENTS, AND ABDOMINAL HEMATOMA IN ONE PATIENT. READMISSIONS OF SEVEN PATIENTS AND REOPERATIONS OF FIVE PATIENTS WERE REPORTED. THE IMPACT OF POWERED CIRCULAR STAPLERS ON ANASTOMOTIC LEAK IN LEFT-SIDED COLORECTAL CANCER SURGERIES: HAYOUNG LEE, SURGICAL ENDOSCOPY (2024) 38:6111¿6119. 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2115582 UNKNOWN EEA STAPLE, IMPLANTABLE GDW US SURGICAL PUERTO RICO UNKNOWN EEA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Life Threatening| R SEE H11