BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION

    MDR report key: 2103414 · Received May 20, 2011

    Report

    Report Number
    MW5020701
    Event Type
    Injury
    Date Received
    May 20, 2011
    Date of Event
    May 3, 2011
    Report Date
    May 20, 2011
    Product Code
    FCX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT A TRANSANAL ENDOSCOPIC MICROSCOPIC SURGERY, PROCTOSCOPY ON (B)(6) 2011. THE PT REQUIRED RETURN TO SURGERY ON (B)(6) 2011 FOR PROCTOSCOPY, DIAGNOSTIC LAPAROSCOPY AND REPAIR OF AN ANASTOMOTIC LEAK. THE PRIMARY PROBLEM WAS INSUFFICIENT INSUFFLATION AND CONTROL OF INSUFFLATION, MAKING IT IMPOSSIBLE TO SEE THE LUMEN AND COMPLETE THE ANASTOMOSIS SATISFACTORILY. INSUFFLATION ISSUES ARE COMMON WITH THE TEM SET, OFTEN RELATED TO LEAKS OF ANY NUMBER OF LOCATIONS, BUT RARELY DUE TO MACHINE MALFUNCTION. WE WERE ABLE TO DO THE RESECTION WITHOUT TOO MUCH DIFFICULTY, BUT ONCE THE PERITONEAL CAVITY WAS OPENED THROUGH THE ANTERIOR RECTAL WALL, THE TISSUES COLLAPSED AND WE WERE NO LONGER ABLE TO MAINTAIN INSUFFLATION. WE WERE ABLE TO SEE A LITTLE USING A HAND BULB INSUFFLATOR LIKE THAT USED FOR A PROCTOSCOPE, BUT WERE NOT AT ALL CONFIDENT THAT THE DEFECT WAS ADEQUATELY CLOSED OR THAT THE LUMEN WAS PATENT. THEREFORE, THE PT WAS RETURNED TO THE OPERATING ROOM THE FOLLOWING MORNING FOR PROCTOSCOPY AND LAPAROSCOPIC REPAIR OF THE DEMONSTRATED RECTAL WALL DEFECT. HE HAD A BOWEL PREP PRIOR TO THE FIRST PROCEDURE AND THERE WAS NO VISIBLE SPILLAGE OR INFLAMMATION IN THE PERITONEAL CAVITY. THIS APPEARS TO HAVE BEEN QUITE SUCCESSFUL, ALTHOUGH THERE IS SOME UNCERTAINTY ABOUT THE PATENCY OF THE LUMEN. NORMALLY, THIS IS AN OUTPATIENT PROCEDURE. THE PLAN FOR THIS PT WAS PRE-OP ADMISSION AND SHORT STAY BECAUSE OF PSYCHIATRIC AND SOCIAL ISSUES. THE RICHARD WOLF COMPANY REP REPLACED THE INSUFFLATION DEVICE WITH A LOANER AFTER THE PREVIOUS CASE THE WEEK BEFORE WHEN THE INSUFFLATION WAS POOR BUT WE WERE ABLE TO COMPLETE THE CASE. SUSPICION LIES WITH THE SCOPE AND FACEPLATES, NOT JUST THE INSUFFLATOR AND WE SHOULD ASK THE COMPANY TO REPLACE THE WHOLE SET. THE PHYSICIAN IS AN INTERNATIONAL PROPONENT OF THE TECHNIQUE WHOM RICHARD WOLF KNOWS WELL. THE PHYSICIAN HAS NO FINANCIAL RELATIONSHIP WITH RICHARD WOLF. THE EQUIPMENT WAS BOUGHT WHEN THE PHYSICIAN CAME TO THE MEDICAL CTR IN (B)(6) 2009 AND SHOULD LAST FOR MANY YEARS. THE PHYSICIAN'S PRIOR SETS AT OTHER FACILITIES LASTED WELL OVER TEN YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION INSUFFLATOR FCX 2232.644
    2 RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION INSUFFLATOR FCX 2231.641
    3 RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION TEMP PUMP LOANER FDC 2232.664

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| S