BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STAPLING DEVICE

    MDR report key: 13874566 · Received March 24, 2022

    Report

    Report Number
    1219930-2022-01025
    Event Type
    Injury
    Date Received
    March 24, 2022
    Date of Event
    October 5, 2021
    Report Date
    April 20, 2022
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    TITLE: INFLUENCE OF PRE-OPERATIVE HBA1C ON BARIATRIC SURGERY OUTCOMES¿THE SUNDERLAND (UK) EXPERIENCE SOURCE: OBESITY SURGERY (2022) 32:42¿47. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5, G3, H6 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.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE SOURCE OF STUDY PERFORMED BETWEEN JANUARY 2014 AND APRIL 2018, A RETROSPECTIVE STUDY EVALUATED COMPLICATION RATES IN PATIENTS WHO UNDERWENT LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS (LRYGB), ONE-ANASTOMOSIS GASTRIC BYPASS (OAGB) AND LAPAROSCOPIC SLEEVE GASTRECTOMY (LSG). IN LRYGB, ENDO HERNIA STAPLER CLIPS WERE USED TO CLOSE THE MESENTERIC AND PETERSON SPACE. IN LSG, ENDO GIA 60MM WITH PURPLE AND GOLD CARTRIDGES WERE USED TO CREATE THE POUCH. IN OAGB, THE POUCH WAS CREATED WITH A TRISTAPLE 45MM PURPLE AND 60MM GOLD STAPLER. A STAPLER WAS ALSO USED FOR THE ANASTOMOSIS. THERE WERE 1419 PATIENTS IN THE STUDY: OAGB 175 PATIENTS, LSG 157 PATIENTS AND LRYGB 1087 PATIENTS. COMPLICATIONS INCLUDED: POSTOPERATIVE BLEEDING (7), ANASTOMOTIC LEAK (1), BOWEL OBSTRUCTION (1), ABDOMINAL INFECTION (1)AND ANASTOMOTIC KINK (1). REOPERATION WAS REQUIRED FOR POSTOPERATIVE BLEEDING, ANASTOMOTIC LEAK, ANASTOMOTIC KINK AND ABDOMINAL INFECTION. BLEEDING IN OTHER PATIENTS REQUIRED ENDOSCOPIC TREATMENT AND CONVERSION TO OPEN SPLENECTOMY. THE BOWEL OBSTRUCTION WAS TREATED CONSERVATIVELY. READMISSIONS WERE ALSO REPORTED.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE SOURCE OF STUDY PERFORMED BETWEEN (B)(6) 2014 AND (B)(6) 2018, A RETROSPECTIVE STUDY EVALUATED COMPLICATION RATES IN PATIENTS WHO UNDERWENT LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS (LRYGB), ONE-ANASTOMOSIS GASTRIC BYPASS (OAGB) AND LAPAROSCOPIC SLEEVE GASTRECTOMY (LSG). IN LRYGB, ENDO HERNIA STAPLER CLIPS WERE USED TO CLOSE THE MESENTERIC AND PETERSON SPACE. IN LSG, ENDO GIA 60MM WITH PURPLE AND GOLD CARTRIDGES WERE USED TO CREATE THE POUCH. IN OAGB, THE POUCH WAS CREATED WITH A TRISTAPLE 45MM PURPLE AND 60MM GOLD STAPLER. A STAPLER WAS ALSO USED FOR THE ANASTOMOSIS. THERE WERE 1419 PATIENTS IN THE STUDY: OAGB 175 PATIENTS, LSG 157 PATIENTS AND LRYGB 1087 PATIENTS. COMPLICATIONS INCLUDED: POSTOPERATIVE BLEEDING (7), ANASTOMOTIC LEAK (1), BOWEL OBSTRUCTION (1), ABDOMINAL INFECTION (1)AND ANASTOMOTIC KINK (1). REOPERATION WAS REQUIRED FOR POSTOPERATIVE BLEEDING, ANASTOMOTIC LEAK, ANASTOMOTIC KINK AND ABDOMINAL INFECTION. BLEEDING IN OTHER PATIENTS REQUIRED ENDOSCOPIC TREATMENT AND CONVERSION TO OPEN SPLENECTOMY. THE BOWEL OBSTRUCTION WAS TREATED CONSERVATIVELY. READMISSIONS WERE ALSO REPORTED. COMPLICATIONS MENTIONED IN THE ARTICLE ARE NOT DIRECTLY RELATED TO ISSUES WITH MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    924298 UNKNOWN STAPLING DEVICE STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN UNKNOWN STAPLING DEVICE

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H