BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONOSURG SHORT HOOK 5MM O.D.

    MDR report key: 12888754 · Received November 29, 2021

    Report

    Report Number
    8010047-2021-15224
    Event Type
    Injury
    Date Received
    November 29, 2021
    Date of Event
    November 10, 2021
    Report Date
    February 14, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    LFL
    UDI-DI
    04953170152375
    PMA / PMN Number
    K050885
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON 2022/1/24, THE LITERATURE WAS REVIEWED BY OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) AND MEDICAL SAFETY OFFICER (MSO), WHO HAS THE MEDICAL LICENSE. THE LITERATURE WROTE, "IN THE CASE OF HAND-SEWN OCCLUSION OF THE PANCREATIC CUT END, THE PANCREATIC PARENCHYMA WAS TRANSECTED USING AN ULTRASONIC COAGULATING DISSECTOR (SONOSURG; OLYMPUS OPTICAL CO. LTD., TOKYO, JAPAN). THE MAIN PANCREATIC DUCT WAS LIGATED, AND THE CUT END OF THE PANCREATIC PARENCHYMA WAS OCCLUDED USING THE INTERRUPTED HAND-SEWN TECHNIQUE.¿ THEREFORE, OMSC AND MSO ESTIMATED THAT THE OCCURRENCE OF POSTOPERATIVE PANCREATIC JUICE LEAKAGE WAS CAUSED BY A SEALED STAPLER OR HAND-SEWN TECHNIQUE. IN ADDITION, THE LITERATURE REPORTED THAT POSTOPERATIVE PANCREATIC JUICE LEAKAGE OF DISTAL PANCREATECTOMY IS GENERALLY 11.0 - 49.1%. HOWEVER, 34.0% OF POSTOPERATIVE PANCREATIC JUICE LEAKAGE OF DISTAL PANCREATECTOMY IN THIS STUDY WAS WITHIN 11.0 - 49.1%. SO, OMSC AND MSO ESTIMATED THAT IT IS UNLIKELY THAT PANCREATIC JUICE LEAKAGE WAS CAUSED BY THE DEVICE.

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS. THEREFORE, THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. SINCE THE LOT NUMBER IS UNKNOWN, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. HOWEVER, OMSC HAS ONLY SHIPPED DEVICES THAT PASSED THE INSPECTION. IN THE LITERATURE, THERE WAS NO DESCRIPTION OF THE DEVICE'S MALFUNCTION.

    Description of Event or Problem · 0

    ON NOVEMBER 25, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED THE LITERATURE "OPTIMAL MANAGEMENT OF PERIPANCREATIC FLUID COLLECTION WITH POSTOPERATIVE PANCREATIC FISTULA AFTER DISTAL PANCREATECTOMY: SIGNIFICANCE OF COMPUTED TOMOGRAPHY VALUES FOR PREDICTING FLUID INFECTION¿. THE PURPOSE OF THE LITERATURE WAS TO EVALUATE THE MANAGEMENT AND OUTCOMES OF PATIENTS WITH POSTOPERATIVE PANCREATIC FISTULA (POPF) AND VERIFY THE SIGNIFICANCE OF COMPUTED TOMOGRAPHY VALUES FOR PREDICTING PERIPANCREATIC FLUID INFECTIONS AFTER DISTAL PANCREATECTOMY. THE OPEN AND LAPAROSCOPIC DISTAL PANCREATECTOMY WAS PERFORMED USING SONOSURG (OLYMPUS) WITH THE HAND-SEWN OR STAPLED CLOSURE TECHNIQUE. THE INCIDENCE AND GRADE OF POPF SEVERITY WERE DETERMINED ACCORDING TO THE 2016 INTERNATIONAL STUDY GROUP FOR PANCREATIC SURGERY (ISGPS) CLASSIFICATION. POSTOPERATIVE COMPLICATIONS WERE EVALUATED USING THE CLAVIEN¿DINDO CLASSIFICATION OF SURGICAL COMPLICATIONS AND STRATIFIED AS GRADES I¿V. IN THE LITERATURE, IT WAS REPORTED 30 CASES OF BIOCHEMICAL LEAKS (BL), 85 CASES OF POPF CLASSIFIED AS GRADE B, 3 CASES OF POPF CLASSIFIED AS GRADE C, AND 1 CASE OF DEATH. ACCORDING TO ISGPS CLASSIFICATION, ¿CONSEQUENTLY, THE FORMER "GRADE A POSTOPERATIVE PANCREATIC FISTULA" IS NOW REDEFINED AND CALLED A "BIOCHEMICAL LEAK," BECAUSE IT HAS NO CLINICAL IMPORTANCE AND IS NO LONGER REFERRED TO A TRUE PANCREATIC FISTULA.¿ THEREFORE, 30 CASES OF BLS MIGHT BE NOT SERIOUS INJURY. HOWEVER, 85 CASES OF POPF CLASSIFIED AS GRADE B AND 3 CASES OF POPF CLASSIFIED AS GRADE C MIGHT BE SERIOUS INJURY, BECAUSE THE LITERATURE WROTE ¿A TOTAL OF 70 PATIENTS (27.0%) DEVELOPED CDC GRADE IIIA COMPLICATIONS¿, WHICH INCLUDED IN THE CASES OF POPF CLASSIFIED AS GRADE B AND C. ALSO, THE LITERATURE WROTE, ¿IN THIS STUDY, ONE PATIENT WITHOUT A POPF DIED FROM AN UNKNOWN CAUSE ON POD 25.¿ BASED ON THE AVAILABLE INFORMATION, A DIRECT RELATIONSHIP BETWEEN THE OLYMPUS PRODUCT AND THESE COMPLICATIONS COULD NOT BE DETERMINED. HOWEVER, 85 CASES OF POPF CLASSIFIED AS GRADE B AND 3 CASES OF POPF CLASSIFIED AS GRADE C MIGHT BE SERIOUS INJURY, AND SONOSURG MIGHT BE ASSOCIATED WITH THE CASES. THIS IS THE REPORT REGARDING 85 CASES OF POPF CLASSIFIED AS GRADE B AND 3 CASES OF POPF CLASSIFIED AS GRADE C.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1779264 SONOSURG SHORT HOOK 5MM O.D. ULTRASONIC SURGICAL DEVICE LFL OLYMPUS MEDICAL SYSTEMS CORP. T3080 04953170152375

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other