BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE ILS CIRCULAR STAPLER

    MDR report key: 4447480 · Received January 23, 2015

    Report

    Report Number
    3005075853-2015-00636
    Event Type
    Injury
    Date Received
    January 23, 2015
    Date of Event
    December 31, 2014
    Report Date
    January 8, 2015
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    KOG
    PMA / PMN Number
    K940967
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).. ADDITIONAL INFORMATION: ADDITIONAL INFORMATION RECEIVED: WHAT IS THE PATIENTS CURRENT CONDITION? THE PATIENT IS DOING FINE/NORMAL. IS THE PRODUCT CODE ECD25 OR ECS25A? ECS25A. HOW WAS THE ANVIL INTRODUCED? THROUGH THE REMNANT WITH AN ARTICULATING MARYLAND WHEN THE DEVICE WAS FIRED, WHAT WAS THE LOCATION OF THE INDICATOR WITHIN THE GAP SETTING SCALE (TOP/THIN, MIDDLE/MEDIUM, BOTTOM/THICK)? TOP/THIN. TIGHTENED AS FAR DOWN AS IT COULD GO. HOW DID YOU CONFIRM THE DEVICE WAS FULLY FIRED (SUCH AS CRUNCH, COMPRESSED UNTIL UNABLE TO FIRE FURTHER, ETC.)? ALL OF THE ABOVE. WAS EGJ COMPLETED? EGJ NOT COMPLETED PER ROUTINE. HOW DID THE PATIENT PRESENT THE BLEED? NAUSEA, BLOODY VOMIT. HOW LONG AFTER THE PRIMARY PROCEDURE DID THE PATIENT PRESENT? 6 HOURS AFTER PROCEDURE WERE ANY BLOOD PRODUCTS GIVEN TO THE PATIENT? BLOOD PRODUCTS WERE GIVEN TO PATIENT, PAXIL. WHAT WERE THE OBSERVED STAPLE FORMS FOR THE FIRST AND SECOND PROCEDURE? ALL STAPLES SEEMED TO BE FORMED PROPERLY. STAPLE LINES LOOKED GOOD. HOW WAS THE LEAK REPAIRED? NO LEAK, BLEED ONLY. WHO FIRED THE DEVICE IN THE FIRST PROCEDURE? FELLOW FIRED THE DEVICE UNDER DIRECT SUPERVISION. WAS THE G TO J ANTE OR RETRO-GASTRIC? ANTE-GASTRIC. WAS THE FIRING ACROSS A STAPLE LINE? YES! AS ALWAYS.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: REPORT ERRED FOR DUPLICATE, RESENT. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: WHAT IS THE PATIENT¿S CURRENT CONDITION? IS THE PRODUCT CODE ECD25 OR ECS25A? HOW WAS THE ANVIL INTRODUCED? WHEN THE DEVICE WAS FIRED, WHAT WAS THE LOCATION OF THE INDICATOR WITHIN THE GAP SETTING SCALE (TOP/THIN, MIDDLE/MEDIUM, BOTTOM/THICK)? HOW DID YOU CONFIRM THE DEVICE WAS FULLY FIRED (SUCH AS CRUNCH, COMPRESSED UNTIL UNABLE TO FIRE FURTHER, ETC.)? WAS EGJ COMPLETED? HOW DID THE PATIENT PRESENT THE BLEED? HOW LONG AFTER THE PRIMARY PROCEDURE DID THE PATIENT PRESENT? WERE ANY BLOOD PRODUCTS GIVEN TO THE PATIENT? WHAT WERE THE OBSERVED STAPLE FORMS FOR THE FIRST AND SECOND PROCEDURE? HOW WAS THE LEAK REPAIRED? WHO FIRED THE DEVICE IN THE FIRST PROCEDURE? WAS THE G TO J ANTE OR RETRO-GASTRIC? WAS THE FIRING ACROSS A STAPLE LINE?

    Additional Manufacturer Narrative · 1

    (B)(4). THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: WHAT IS THE PATIENT¿S CURRENT CONDITION? IS THE PRODUCT CODE ECD25 OR ECS25A? HOW WAS THE ANVIL INTRODUCED? WHEN THE DEVICE WAS FIRED, WHAT WAS THE LOCATION OF THE INDICATOR WITHIN THE GAP SETTING SCALE (TOP/THIN, MIDDLE/MEDIUM, BOTTOM/THICK)? HOW DID YOU CONFIRM THE DEVICE WAS FULLY FIRED (SUCH AS CRUNCH, COMPRESSED UNTIL UNABLE TO FIRE FURTHER, ETC.)? WAS EGJ COMPLETED? HOW DID THE PATIENT PRESENT THE BLEED? HOW LONG AFTER THE PRIMARY PROCEDURE DID THE PATIENT PRESENT? WERE ANY BLOOD PRODUCTS GIVEN TO THE PATIENT? WHAT WERE THE OBSERVED STAPLE FORMS FOR THE FIRST AND SECOND PROCEDURE? HOW WAS THE LEAK REPAIRED? WHO FIRED THE DEVICE IN THE FIRST PROCEDURE? WAS THE G TO J ANTE OR RETRO-GASTRIC? WAS THE FIRING ACROSS A STAPLE LINE?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LAPAROSCOPIC ROUX-EN-Y PROCEDURE WAS PERFORMED AND THE PROCEDURE WAS COMPLETED WITH NO PATIENT CONSEQUENCE. POST-OP THE PATIENT WAS TAKEN BACK INTO THE OR FOR A LAPAROSCOPY AND IT WAS NOTICED THAT THERE WAS BLEEDING AT THE CONNECTION OF THE SMALL BOWEL AND STOMACH. IT IS UNKNOWN WHAT CAUSED THE BLEEDING OR HOW THE BLEEDING WAS CONTROLLED. UNKNOWN IF A TRANSFUSION WAS REQUIRED. UNKNOWN PATIENTS CURRENT CONDITION. THE REP HAS NO FURTHER INFORMATION AT THIS TIME. THE DEVICE WAS DISCARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LAPAROSCOPIC ROUX-EN-Y PROCEDURE WAS PERFORMED AND THE PROCEDURE WAS COMPLETED WITH NO PATIENT CONSEQUENCE. POST-OP THE PATIENT WAS TAKEN BACK INTO THE OR FOR A LAPAROSCOPY AND IT WAS NOTICED THAT THERE WAS BLEEDING AT THE CONNECTION OF THE SMALL BOWEL AND STOMACH. IT IS UNKNOWN WHAT CAUSED THE BLEEDING OR HOW THE BLEEDING WAS CONTROLLED. UNKNOWN IF A TRANSFUSION WAS REQUIRED. UNKNOWN PATIENTS CURRENT CONDITION. THE REP HAS NO FURTHER INFORMATION AT THIS TIME. THE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56619 PROXIMATE ILS CIRCULAR STAPLER ENDOSCOPE AND/OR ACCESSORIES KOG ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1