BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE I L S INTRALUMINAL STAPLER

    MDR report key: 107763 · Received July 24, 1997

    Report

    Report Number
    1527736-1997-01774
    Event Type
    Injury
    Date Received
    July 24, 1997
    Date of Event
    June 23, 1997
    Report Date
    June 25, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT COMPLAINT ANALYSIS TEAMHAD COMPLETED ITS INVESTIGATION OF THE DEVICE WHICH WAS RETURNED TO CO WITH PRODUCT INQUIRY #973986. VISUAL INSPECTIONS & RESULTS: DAMAGED ANVIL / ANVIL SHROUD, N/A; DAMAGED GUIDE FACE, AB-NO; DAMAGED KNIFE, AB-NO; DAMAGED OTHER, AB-NO; DAMAGED STAPLE POCKETS, AB-NO; DAMAGED TROCAR, AB-NO AND MISSING PARTS, AB-ANVIL. ANALYSIS CONCLUSION: BASED ON INFO RECEIVED AND VISUAL INSPECTION, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED REPORTED INCIDENT. AS ANVILS WERE NOT RETURNED WITH INSTRUMENTS, FURTHER FUNCTIONAL TESTING COULD NOT BE PERFORMED. HOWEVER, BOTH INSTRUMENTS WERE CYLCED AND THERE WERE NO DIFFICULTIES NOTED WITH THE INSTRUMENTS BEING DIALED INTO FIRING RAGNE. THE MFG ENGINEER HAS BEEN NOTIFIED OF REPORTED INCIDENT. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT IS REPORTED IN ORDER TO CONTINUOULSY IMPROVE CO'S PRODUCTS.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A LOW ANTERIOR RESECTION THE SURGEON ATTEMPTED TO USE A CDH25 TO REANASTOMOSE THE BOWEL. AFTER TYING THE PURSE STRING, THE ANVIL PORTION WOULD NOT CLICK ONTO THE STAPLER PORTION. THE SURGEON HAD GRASPED THE ANVIL PORTION WITH A MAYO CLAMP INSTEAD OF ANVIL GRASPER. THE STAPLER WAS REMOVED AND ANOTHER CDH OPENED. IT CLICKED TOGETHER CORRECTLY AND SEEMED TO FIRE NORMALLY, STAPLED AND CUT, BUT ONLY PRODUCED A PROXIMAL TISSUE RING. THE DISTAL RING COULD NOT BE FOUND IN THE STAPLER. WHEN TESTING THE ANASTOMOSIS, IT FELL APART. THE SURGEON USED AN EEA TO COMPLETE THE CASE, BUT FELT UNSURE ABOUT THE ANASTOMOSIS. THE SURGEON SAID EACH TIME THE STAPLER DID NOT WORK HE HAD TO EXCISE A LITTLE MORE TISSUE, AND THE ANASTOMOSIS WAS DONE ON TISSUE UNDER TENSION AND TISSUE QUALITY WAS NOT GOOD. A DIVERTING COLOSTOMY WAS DONE, IT MAY BE REATTACHED LATER. THE ANVILS FROM BOTH STAPLERS WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE I L S INTRALUMINAL STAPLER CIRCULAR STAPLERS GAG ETHICON ENDO-SURGERY, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other