BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VLOC PRODUCT

    MDR report key: 14553682 · Received May 31, 2022

    Report

    Report Number
    1219930-2022-02028
    Event Type
    Injury
    Date Received
    May 31, 2022
    Date of Event
    July 13, 2021
    Report Date
    August 15, 2022
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GAM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    TITLE: A SAFETY STUDY OF LAPAROSCOPIC SINGLE-ANASTOMOSIS DUODENO-ILEAL BYPASS WITH GASTRIC PLICATION (SADI-GP) IN THE MANAGEMENT OF MORBID OBESITY SOURCE: LANGENBECK'S ARCHIVES OF SURGERY (2022) 407:845¿860 HTTPS://DOI.ORG/10.1007/S00423-021-02276-9 RECEIVED: 21 APRIL 2021 / ACCEPTED: 13 JULY 2021 © THE AUTHOR(S) 2021. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCT: UNKNOWN EGIA SU UNKNOWN ENDO GIA SULU UNK, UNKNOWN ENDO GI UNKNOWN ENDO GIA INSTRUMENT UNK. NEW INFORMATION HAS BEEN RECEIVED, AND REASSESSMENT OF THE COMPLAINT FOUND THAT IT IS NO LONGER A REPORTABLE ISSUE. 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. 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

    ADDITIONAL INFORMATION: A2, A3, A4, B5, G3 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.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE, A STUDY ANALYZED OUTCOMES OF PATIENTS WHO UNDERWENT SINGLE-ANASTOMOSIS DUODENO-ILEAL BYPASS WITH SLEEVE GASTRECTOMY BETWEEN OCTOBER 2018 AND NOVEMBER 2019. AN 60MM RELOAD WAS USED TO TRANSECT THE DUODENUM. THERE WERE 17 PATIENTS IN THE STUDY AND ONE PATIENT EXPERIENCE POSTOPERATIVE ANASTOMOSIS LEAKAGE REQUIRING REOPERATION (TREATED LAPAROSCOPICALLY BY STITCHES). PULMONARY INSUFFICIENCY AND VOMITING WERE NOT RELATED TO THE DEVICES.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE, A STUDY ANALYZED OUTCOMES OF PATIENTS WHO UNDERWENT SINGLE-ANASTOMOSIS DUODENO-ILEAL BYPASS WITH SLEEVE GASTRECTOMY BETWEEN (B)(6) 2018 AND (B)(6) 2019. AN END-TO-SIDE DUODENO-ILEOSTOMY ANASTOMOSIS WAS PERFORMED USING THE SUTURE. THERE WERE 17 PATIENTS IN THE STUDY AND ONE FEMALE PATIENT EXPERIENCE POSTOPERATIVE ANASTOMOSIS LEAKAGE AS RESULT OF A TECHNICAL FAILURE REQUIRING REOPERATION (TREATED LAPAROSCOPICALLY BY STITCHES). IT WAS NOTED THAT ALTHOUGH CAUSE OF LEAKAGE WAS UNKNOWN, THE SUTURE DID NOT CAUSE THE LEAKAGE.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE, A STUDY ANALYZED OUTCOMES OF PATIENTS WHO UNDERWENT SINGLE-ANASTOMOSIS DUODENO-ILEAL BYPASS WITH SLEEVE GASTRECTOMY BETWEEN OCTOBER 2018 AND NOVEMBER 2019. A 60MM RELOAD WAS USED TO TRANSECT THE DUODENUM. THERE WERE 17 PATIENTS IN THE STUDY AND ONE FEMALE PATIENT EXPERIENCE POSTOPERATIVE ANASTOMOSIS LEAKAGE REQUIRING REOPERATION (TREATED LAPAROSCOPICALLY BY STITCHES).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317698 UNKNOWN VLOC PRODUCT SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC GAM COVIDIEN LP LLC NORTH HAVEN UNKNOWN VLOC PRODUCT

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Required Intervention