BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*75MM LINEAR CUTTER

    MDR report key: 11633612 · Received April 8, 2021

    Report

    Report Number
    3005075853-2021-01838
    Event Type
    Injury
    Date Received
    April 8, 2021
    Date of Event
    January 1, 2021
    Report Date
    April 2, 2021
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036013211
    PMA / PMN Number
    K020779
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 05/10/2021. H11: CORRECTED DATA = B5; NO DEATH ASSOCIATED TO THE LINEAR STAPLER 75MM.

    Description of Event or Problem · 0

    TITLE: (B)(6). THE AIM OF THIS RETROSPECTIVE STUDY IS TO COMPARE THE POSTOPERATIVE RESULTS OF HANDSEWN GASTROJEJUNOSTOMY (HGJ) AND STAPLED ASTROJEJUNSTOMY (SGJ) LIMITED TO PYLORUS-RESECTING PANCREATICODUODENECTOMY (PRPD) PERFORMED BY A SINGLE SURGEON. BETWEEN (B)(6) 2014 TO (B)(6) 2020, A TOTAL OF 131 PATIENTS WHO UNDERWENT PYLORUS-RESECTING PANCREATICODUODENECTOMY (PRPD) WERE INCLUDED IN THE STUDY. OF THESE, 90 PATIENTS (44 MALE AND 46 FEMALE; MEAN AGE = 66.6±11.6 YEARS; BMI = 23.0±3.2) UNDERWENT HANDSEWN GASTROJEJUNOSTOMY (HGJ) USING VICRYL PLUS 3/0 (ETHICON), AND 41 PATIENTS (25 MALE AND 17 FEMALE; MEAN AGE = 66.7±9.5; BMI = 22.7±3.1) UNDERWENT STAPLED GASTROJEJUNOSTOMY (SGJ) USING A LINEAR STAPLER 75 MM (ETHICON LINEAR CUTER NTLC75). REPORTED COMPLICATIONS INCLUDED IN THE HGJ GROUP WERE DELAYED GASTRIC EMPTYING GRADE A (N=3); DELAYED GASTRIC EMPTYING GRADE B (N=6); DELAYED GASTRIC EMPTYING GRADE C (N=11); INTRA-ABDOMINAL FLUID COLLECTION (N=5); ILEUS (N=2); CLAVIEN-DINDO CLASSIFICATION GRADE I-II (N=83); CLAVIEN-DINDO CLASSIFICATION GRADE IIIA-IIIB (N=5); CLAVIEN-DINDO CLASSIFICATION GRADE IV-V (N=1); POSTOPERATIVE BLEEDING (N=1); AND UNKNOWN EVENT WHICH REQUIRED TRANSFUSION (N=8). IN THE SGJ GROUP WERE DELAYED GASTRIC EMPTYING GRADE A (N=5); INTRA-ABDOMINAL FLUID COLLECTION (N=6); ILEUS (N=1); CLAVIEN-DINDO CLASSIFICATION GRADE I-II (N=37); CLAVIEN-DINDO CLASSIFICATION GRADE IIIA-IIIB (N=4); UNKNOWN EVENT WHICH REQUIRED TRANSFUSION (N=1); AND 30-DAY MORTALITY (N=1). IN CONCLUSION, THIS STUDY SUGGESTS THAT STAPLED GJ SHORTENS RECONSTRUCTION TIME DURING PRPD WITHOUT AFFECTING THE INCIDENCE OF DGE. THEREFORE, USING A STAPLER FOR THE GJ IS FEASIBLE AND SAFE TECHNIQUE.

    Additional Manufacturer Narrative · 1

    (B)(4). ONLY EVENT YEAR KNOWN: 2021; CAPTURED AS CITATION DATE. BATCH # UNKNOWN. THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT/BATCH NUMBER HAS NOT BEEN PROVIDED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE ACTUAL NUMBER OF PATIENTS IN HGJ AND SGJ GROUP THAT HAD DELAYED GASTRIC EMPTYING (GRADE A, B, C), AS THE TABLE AND THE NARRATIVE DID NOT COINCIDE, AND CAN YOU CONFIRM IF THIS IS A DIRECT RESULT OF THE USE OF THE LINEAR STAPLER 75 MM (ETHICON)? THE SPECIFIC ADVERSE EVENT/REASON IN 8 PATIENTS IN HGJ GROUP AND 1 PATIENT IN SGJ GROUP WHICH REQUIRED TRANSFUSION, AND CAN YOU CONFIRM IF THIS IS A DIRECT RESULT OF THE USE OF THE LINEAR STAPLER 75 MM (ETHICON), RESPECTIVELY? THE ACTUAL NUMBER OF PATIENTS AND THE REASON/CAUSE OF DEATH OR 30-DAY MORTALITY IN SGJ GROUP, AS THE TABLE AND THE NARRATIVE DID NOT COINCIDE, AND CONFIRM IF THIS IS A DIRECT RESULT OF THE USE OF A LINEAR STAPLER 75 MM (ETHICON)?

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: A COMPARATIVE STUDY OF POSTOPERATIVE OUTCOMES AFTER STAPLED VERSUS HANDSEWN GASTROJEJUNAL ANASTOMOSIS FOR PYLORUS-RESECTING PANCREATICODUODENECTOMY AUTHORS: SOOK HYUN LEE, YUN HO LEE, YOUNG HOE HUR, HEE JOON KIM, AND BYUNG GWAN CHOI CITATION: ANN HEPATOBILIARY PANCREAT SURG. 2021; 25: 84-89. DOI: HTTPS://DOI.ORG/10.14701/AHBPS.2021.25.1.84. THE AIM OF THIS RETROSPECTIVE STUDY IS TO COMPARE THE POSTOPERATIVE RESULTS OF HANDSEWN GASTROJEJUNOSTOMY (HGJ) AND STAPLED ASTROJEJUNSTOMY (SGJ) LIMITED TO PYLORUS-RESECTING PANCREATICODUODENECTOMY (PRPD) PERFORMED BY A SINGLE SURGEON. BETWEEN JANUARY 2014 TO MARCH 2020, A TOTAL OF 131 PATIENTS WHO UNDERWENT PYLORUS-RESECTING PANCREATICODUODENECTOMY (PRPD) WERE INCLUDED IN THE STUDY. OF THESE, 90 PATIENTS (44 MALE AND 46 FEMALE; MEAN AGE = 66.6±11.6 YEARS; BMI = 23.0±3.2) UNDERWENT HANDSEWN GASTROJEJUNOSTOMY (HGJ) USING VICRYL PLUS 3/0 (ETHICON), AND 41 PATIENTS (25 MALE AND 17 FEMALE; MEAN AGE = 66.7±9.5; BMI = 22.7±3.1) UNDERWENT STAPLED GASTROJEJUNOSTOMY (SGJ) USING A LINEAR STAPLER 75 MM (ETHICON LINEAR CUTER NTLC75). REPORTED COMPLICATIONS INCLUDED IN THE HGJ GROUP WERE DELAYED GASTRIC EMPTYING GRADE A (N=3); DELAYED GASTRIC EMPTYING GRADE B (N=6); DELAYED GASTRIC EMPTYING GRADE C (N=11); INTRA-ABDOMINAL FLUID COLLECTION (N=5); ILEUS (N=2); CLAVIEN-DINDO CLASSIFICATION GRADE I-II (N=83); CLAVIEN-DINDO CLASSIFICATION GRADE IIIA-IIIB (N=5); CLAVIEN-DINDO CLASSIFICATION GRADE IV-V (N=1); POSTOPERATIVE BLEEDING (N=1); AND UNKNOWN EVENT WHICH REQUIRED TRANSFUSION (N=8). IN THE SGJ GROUP WERE DELAYED GASTRIC EMPTYING GRADE A (N=5); INTRA-ABDOMINAL FLUID COLLECTION (N=6); ILEUS (N=1); CLAVIEN-DINDO CLASSIFICATION GRADE I-II (N=37); CLAVIEN-DINDO CLASSIFICATION GRADE IIIA-IIIB (N=4); UNKNOWN EVENT WHICH REQUIRED TRANSFUSION (N=1); AND 30-DAY MORTALITY (N=1). IN CONCLUSION, THIS STUDY SUGGESTS THAT STAPLED GJ SHORTENS RECONSTRUCTION TIME DURING PRPD WITHOUT AFFECTING THE INCIDENCE OF DGE. THEREFORE, USING A STAPLER FOR THE GJ IS FEASIBLE AND SAFE TECHNIQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536104 PROXIMATE*75MM LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. TLC75 10705036013211

    Patients

    Seq Age Sex Outcome Treatment
    1