BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS

    MDR report key: 163387 · Received April 16, 1998

    Report

    Report Number
    1527736-1998-01161
    Event Type
    Malfunction
    Date Received
    April 16, 1998
    Date of Event
    March 18, 1998
    Report Date
    March 19, 1998
    Manufacturer
    ETHICON ENDO-SURGERY
    Product Code
    KOG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    TRACKING #.50619. EES #.981978/C. D5; H2,3,4,6; G4: ADDED ADDITION INFO D6: CORRECTED FIELD TO READ NA H6; DISLODGED ANVIL. ENDOPATH ETS: BASED UPON THE INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE INSTRUMENT WAS RETURNED WITH THE ANVIL DISLODGED FROM THE CLOSURE TUBE. WHEN THIS CONDITION EXISTS PRESSING THE RELEASE BUTTON WILL NOT OPEN THE INSTRUMENT. THE ANVIL WAS RE-ALIGNED AND THE INSTRUMENT WAS CYCLED, FIRED, CUT, AND FORMED THE STAPLES WITHIN DESIGN SPECIFICATION. THE INQUIRY WAS ORIGINALLY REPORTED AS AN RPO "RECORD PURPOSE ONLY."

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY A TSW35 ONLY LAID DOWN HALF OF THE STAPLE LINE AND DID NOT CUT ACROSS THE UTERO-OVARIAN PEDICLE. IT WAS HARD TO FIRE AND TO RELEASE OFF THE TISSUE. ANOTHER TSW35 WAS OPENED TO COMPLETE THE CASE. THE INSTURMENT WAS DISCARDED BY HOSP PERSONNEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS LINEAR CUTTERS - ENDOSCOPIC KOG ETHICON ENDO-SURGERY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other