BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUR-FIT LOOP OSTOMY ROD 65MM

    MDR report key: 7122643 · Received December 15, 2017

    Report

    Report Number
    1049092-2017-00090
    Event Type
    Injury
    Date Received
    December 15, 2017
    Date of Event
    November 22, 2017
    Product Code
    EZP
    PMA / PMN Number
    EXEMPT
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, HOWEVER TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE LAST THREE (3) PRODUCT MONITORING REVIEW¿S FOR TRENDS INDICATED NO TRENDS FOR THIS ISSUE ON THIS PRODUCT. THE HISTORICAL COMPLAINT DATA FROM NOVEMBER 01, 2015 TO NOVEMBER 30, 2017 WAS REVIEWED AS IT RELATES TO REPORTS FOR PRODUCT PART NUMBER 22355. A TOTAL OF ONE (1) COMPLAINT, INCLUDING THIS ONE, WAS REPORTED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED BY A REPRESENTATIVE AT (B)(6) HOSPITAL THAT WHILE PERFORMING SURGERY A PIECE OF THE LOOP OSTOMY ROD DROPPED INSIDE THE PATIENT DURING THE OPERATION DUE TO A MALFUNCTION. ACCORDING TO THE REPORTER, THE PRODUCT APPEARED INTACT WHEN OPENING IT. IT WAS USED TO ASSIST THE SURGEON ON GETTING THE LOOP OF BOWEL OUT OF THE ABDOMEN, WHICH, ACCORDING TO THE REPORTER, PROVED QUITE DIFFICULT. WHEN THEY FINALLY GOT THE LOOP OF THE BOWEL OUT THEY REALIZED ¿THE MOVING (ARROW SHAPED) PART THAT SPINS AROUND HAD COME OFF FROM THE ROD. IT HAD SIMPLY SNAPPED OFF WHERE THE TWO PIECES MEET.¿ THE REPORTER SAID THE SURGICAL TEAM PUT THE LAPAROSCOPIC PORTS BACK IN TO RE-INFLATE THE ABDOMEN TO LOOK WHERE THE PIECE HAD GONE. ACCORDING TO THE REPORTER, ¿IT WAS FOUND INSIDE THE ABDOMEN, LYING ON TOP OF THE BOWEL.¿ THEY TRIED TO GET IT OUT WITH DIFFERENT FORCEPS BUT THIS PROVED UNSUCCESSFUL. IN THE END THEY USED A ¿RETRIEVAL POUCH (NORMALLY USED FOR APPENDIXES) TO DROP THE ROD INSIDE AND THEN RETRIEVE THE WHOLE THING.¿ THERE WAS NO INJURY TO THE PATIENT OR THE STOMA. THE REPORTER SAID IT WAS JUST VERY INCONVENIENT AND DELAYED THINGS A BIT. THE REPORTER HAS NO FURTHER INFORMATION REGARDING THE PATIENT OR CURRENT CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    900996 SUR-FIT LOOP OSTOMY ROD 65MM ROD, COLOSTOMY EZP 22355 3M00287

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention