BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRI-STAPLE 2.0

    MDR report key: 15946077 · Received December 8, 2022

    Report

    Report Number
    1219930-2022-04817
    Event Type
    Injury
    Date Received
    December 8, 2022
    Date of Event
    March 16, 2022
    Report Date
    December 19, 2022
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    UDI-DI
    10884521543768
    PMA / PMN Number
    K160176
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    TITLE: A NOVEL IMAGING TECHNOLOGY TO ASSESS OXYGEN SATURATION OF THE GASTRIC CONDUIT IN THORACIC ESOPHAGECTOMY SOURCE: SURGICAL ENDOSCOPY (2022) 36:7597¿7606 HTTPS://DOI.ORG/10.1007/S00464-022-09199-6 ACCEPTED: 16 MARCH 2022 MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    CONCOMITANT PRODUCT: UNKNOWN ENDO GI, UNKNOWN ENDO GIA INSTRUMENT, ADDITIONAL INFORMATION: D4 (MODEL AND CATALOG NUMBER, EXPIRATION DATE, UDI), G4 (510K), H6 NEW INFORMATION HAS BEEN RECEIVED, AND REASSESSMENT OF THE COMPLAINT FOUND THAT IT IS NO LONGER A REPORTABLE EVENT. THE EVENT IS NO LONGER ASSOCIATED WITH A SERIOUS INJURY OR POTENTIAL FOR SERIOUS INJURY WITH REOCCURRENCE. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Description of Event or Problem · 0

    ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED BETWEEN FEBRUARY 2018 AND MARCH 2021, WHICH EVALUATED THE RESULTS IN PATIENTS WHO UNDERWENT THORACIC ESOPHAGECTOMY WITH IMMEDIATE ASSESSMENT OF PERFUSION OF THE GASTRIC CONDUIT. THERE WERE FIFTY ONE (51) PATIENTS IN THE STUDY. THE CONDUIT WAS DESIGNED AS A NARROW GASTRIC TUBE USING THE CURVED-SHAPE STAPLER AS THE FIRST STAPLING. THEN, A LINEAR STAPLER WAS USED. IN FORTY SEVEN (47) PATIENTS, THE ANASTOMOSIS WAS PERFORMED USING THE MODIFIED COLLARD TECHNIQUE WITH A FORTY FIVE MILLIMETERS (45-MM) LINEAR STAPLER POSTERIORLY AND 45-MM AND SIXTY MILLIMETERS (60-MM) LINEAR STAPLERS ANTERIORLY. THE REMAINING FOUR UNDERWENT ANASTOMOSIS USING THE HAND-SEWN TECHNIQUE. POSTOPERATIVE COMPLICATIONS INCLUDED: ANASTOMOTIC LEAKAGE IN 3 PATIENTS (5.8%), ANASTOMOTIC STENOSIS OR STRICTURE IN 4 PATIENTS (7.8%), POSTOPERATIVE PNEUMONIA IN 4 PATIENTS (7.8%) AND VOCAL CORD PARALYSIS IN 16 PATIENTS (31.3%). NO INTERVENTIONS WERE REPORTED.

    Description of Event or Problem · 0

    ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED BETWEEN FEBRUARY 2018 AND MARCH 2021, WHICH EVALUATED THE RESULTS IN PATIENTS WHO UNDERWENT THORACIC ESOPHAGECTOMY WITH IMMEDIATE ASSESSMENT OF PERFUSION OF THE GASTRIC CONDUIT. THERE WERE FIFTY ONE (51) PATIENTS IN THE STUDY. THE CONDUIT WAS DESIGNED AS A NARROW GASTRIC TUBE USING THE CURVED-SHAPE STAPLER AS THE FIRST STAPLING. THEN, A LINEAR STAPLER WAS USED. IN FORTY SEVEN (47) PATIENTS, THE ANASTOMOSIS WAS PERFORMED USING THE MODIFIED COLLARD TECHNIQUE WITH A FORTY FIVE MILLIMETERS (45-MM) LINEAR STAPLER POSTERIORLY AND 45-MM AND SIXTY MILLIMETERS (60-MM) LINEAR STAPLERS ANTERIORLY. THE REMAINING FOUR UNDERWENT ANASTOMOSIS USING THE HAND-SEWN TECHNIQUE. POSTOPERATIVE COMPLICATIONS INCLUDED: ANASTOMOTIC LEAKAGE IN 3 PATIENTS (5.8%), ANASTOMOTIC STENOSIS OR STRICTURE IN 4 PATIENTS (7.8%), POSTOPERATIVE PNEUMONIA IN 4 PATIENTS (7.8%) AND VOCAL CORD PARALYSIS IN 16 PATIENTS (31.3%). NO INTERVENTIONS WERE REPORTED. IT WAS NOTED THAT THE COMPLICATIONS WERE NOT DIRECTLY RELATED TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2908595 TRI-STAPLE 2.0 STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN SIGRADMT 10884521543768

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other SEE H10.