BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLASSMAN VISCERA RETAINER

    MDR report key: 5507327 · Received June 10, 2015

    Report

    Report Number
    2918699-2015-00001
    Event Type
    Injury
    Date Received
    June 10, 2015
    Date of Event
    February 25, 2010
    Report Date
    June 8, 2015
    Manufacturer
    ADEPT-MED INTL., INC.
    Product Code
    GCZ
    PMA / PMN Number
    K802806
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2015, ADEPT-MED WAS CONTACTED BY (B)(6). (B)(6) IS REPRESENTING (B)(6) IN A LAW SUIT NAMING A HOSPITAL AND HOSPITAL STAFF FOR FAILING TO REMOVE A GLASSMAN VISCERA RETAINER FROM (B)(6) ABDOMEN PRIOR TO THE CONCLUSION OF (B)(6) SURGERY ON (B)(6) 2010. THIS FAILURE RESULTED IN (B)(6) REQUIRING A SUBSEQUENT SURGERY TO REMOVE THE RETAINER FROM HIS ABDOMEN. AS ADEPT-MED AND/OR THE RETAINER ARE NOT NAMED AS A PARTY TO THE LAW SUIT, (B)(6) STATED THAT DUE TO CLIENT CONFIDENTIALITY THE ONLY INFORMATION THEY COULD PROVIDE ADEPT-MED REGARDING THIS INCIDENT WAS A PRINTED COPY OF THE DOCUMENTS THAT WERE PUBLIC RECORD I.E. A COPY OF THE LEGAL FILING, THE FOURTH AMENDED COMPLAINT AT LAW, FILED (B)(6) 2014 AND TWO PICTURES OF THE RETAINER TAKEN AFTER ITS REMOVAL FROM (B)(6) ABDOMEN. ADEPT WAS ABLE TO CONFIRM THE DEVICE IN QUESTION WAS IN FACT A GLASSMAN VISCERA RETAINER FROM THE PICTURES. THE INFORMATION IN THIS 3500A WAS OBTAINED FROM THE AFOREMENTIONED LEGAL FILING. (B)(6) CONTACTED ADEPT-MED TO REQUEST "A COPY OF ANY WRITTEN MATERIALS PERTAINING TO THE FISH WHICH WERE AVAILABLE" AT THE TIME OF THE INCIDENT AND TO PURCHASE A RETAINER. WE EXPLAINED THE REQUIREMENT FOR A PHYSICIAN'S ORDER TO SELL THEM A RETAINER, AND SENT THEM THE REQUESTED WRITTEN MATERIALS.

    Description of Event or Problem · 1

    ON (B)(6) 2010 PATIENT (B)(6) WAS "TAKEN TO SURGERY FOR AN EXPLORATORY LAPAROTOMY AND SURGICAL TAKEDOWN OF A COLOSTOMY". ACCORDING TO THE INFORMATION RECEIVED FROM (B)(6) LEGAL REPRESENTATIVE, A GLASSMAN VISCERA RETAINER WAS USED IN THE AFOREMENTIONED SURGERY AND "LEFT IN (B)(6) ABDOMEN AT THE CONCLUSION OF THE SURGERY". "ON (B)(6) 2010, (B)(6) DISCOVERED THAT A SURGICAL INSTRUMENT HAD BEEN RETAINED IN HIS ABDOMEN". (B)(6) REQUIRED SURGERY TO REMOVE THAT INSTRUMENT I.E. A GLASSMAN VISCERA RETAINER. AT ADEPT'S REQUEST, (B)(6) LEGAL REPRESENTATIVE SUPPLIED PICTURES OF THE RETAINED INSTRUMENT WHICH CONFIRMED THAT IT WAS IN FACT A GLASSMAN VISCERA RETAINER. THE GLASSMAN VISCERA RETAINER IS A SINGLE USE, STERILE DISPOSABLE DEVICE THAT FACILITATES CLOSURE OF THE ABDOMINAL CAVITY. IT IS REMOVED FROM THE PATIENT AT THE CONCLUSION OF THE ABDOMINAL CLOSURE. THERE IS A "STRING" ATTACHED TO THE RETAINER, A RING ATTACHED TO THE STRING BOTH OF WHICH RESIDE OUTSIDE THE BODY DURING SURGERY TO INDICATE THAT THE DEVICE IS PRESENT IN THE ABDOMINAL CAVITY. THE RING AND STRING WERE STILL ATTACHED TO THE RETAINER WHEN IT WAS REMOVED FROM (B)(6) ABDOMEN IN THE SURGERY TO REMOVE THE RETAINED SURGICAL INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381166 GLASSMAN VISCERA RETAINER VISCERA RETAINER/FISH GCZ ADEPT-MED INTL., INC. 3204

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention