BEUDAMED
    FDA Adverse Event Other Summary report: N

    REPOSABLE STEP

    MDR report key: 191900 · Received October 14, 1998

    Report

    Report Number
    1721520-1998-00002
    Event Type
    Other
    Date Received
    October 14, 1998
    Date of Event
    October 6, 1998
    Report Date
    October 14, 1998
    Manufacturer
    INNERDYNE, INC.
    Product Code
    DYB
    Removal / Correction Number
    900832
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON THURSDAY, 8 OCTOBER 1998, A REPORT WAS REC'D BY THE INNERDYNE, INC., QUALITY COMPLIANCE DEPARTMENT FROM A SALES REP, REGARDING ONE INCIDENT INVOLVING A REPOSABLE STEP LIMITED RE-USE BARREL. MULTIPLE ATTEMPTS WERE UNDERTAKEN TO CONFIRM THE REPORTED INFO WITH THE INVOLVED PHYSICIAN, WITH UNSUCCESSFUL RESOLUTION. THEREFORE, THE REPORTED INFO DIRECTLY BEARING ON THE EVENT ARE UNSUBSTANTIATED AND UNCONFIRMED. THE EPISODE OCCURRED AT A HOSP DURING A DIGNOSTIC LAPAROSCOPY PROCEDURE ON A FEMALE PT UNDER THE HAND OF A RESIDENT PHYSICIAN,. DURING DILATION OF THE PLACED EXPANDABLE SLEEVE, ADVANCEMENT OF THE CANNULA/DILATOR ASSEMBLY THROUGH THE SLEEVE WAS MET WITH EXTREME RESISTANCE AND REPORTED TO HAVE BECOME CAUGHT ON THE SLEEVE MATERIAL, RESULTING IN RADICAL DILATION THROUGH THE SIDE OF THE EXPANDABLE SLEEVE. IN THIS PROCESS, THE DISTAL TIP OF THE CANNULA WAS INADVERTENTLY FRACTURED AND BECAME DISLODGED. THE DILATOR/CANNULA ASSEMBLY WAS REMOVED FROM THE CREATED TRACT, FOLLOWED BY THE EXPANDABLE SLEEVE, UPON REMOVAL, THE FRACTURE TO THE DISTAL TIP OF THE CANNULA WAS OBSERVED BUT WAS NOT CONTAINED WITH THE REMOVED ITEMS. THROUGH AN ESTABLISHED PORT, A SCOPE WAS PLACED AND THE ABDOMINAL REGION WAS EXTENSIVELY VISUALLY EXAMINED FOR BARREL FRAGMENTS, WITH NOTHING LOCATED. THE FRACTURED BARREL FRAGMENT WAS NEVER ACCOUNTED FOR. THE PROCEDURE WAS BROUGHT TO CONCLUSION AND THE PT WAS CLOSED, TAKEN TO RECOVERY,AND IS REPORTED FINE AT THIS TIME WITHOUT MEDICAL SEQUELAE. THEREFORE, THE EVENT IS REPRORED FOR THE POSSIBLE LEAVING OF A FOREIGN MATERIAL IN THE ABDOMINAL REGION. SECONDARY SURGICAL INTERVENTION, ABOVE AND BEYOND THE ORIGINAL PROCEDURE, WAS NOT UNDERTAKEN. THE FRACTURED/DAMAGED BARREL AND DISRUPTED EXPANDABLE SLEEVE HAS BEEN REQUESTED TO BE RETURNED TO INNERDYNE, INC., BUT HAS NOT BEEN RELEASED BY THE HOSP AT THIS TIME. IF RETURN OF THE IDENTIFIED ARTICLES OCCURS, A FULL EXAMINATION WILL BE UNDERTAKEN AND DOCUMENTED ACCORDING TO ESTABLISHED PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPOSABLE STEP 10MM S/C/D DYB INNERDYNE, INC. RS901010 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other