BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN VERSASTEP

    MDR report key: 4838392 · Received June 11, 2015

    Report

    Report Number
    9612501-2015-00306
    Event Type
    Malfunction
    Date Received
    June 11, 2015
    Date of Event
    May 15, 2015
    Report Date
    August 26, 2015
    Manufacturer
    COVIDIEN
    Product Code
    GCJ
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE 510K #S: VS101005: K012539 AND VS101000: K012539.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE OPENED BY THE ACCOUNT. THIS EVALUATION WAS BASED ON A TECHNICAL REVIEW OF ALL DATA RECEIVED FROM THE SITE, A PMV REVIEW OF MANUFACTURING RECORDS, A PMV REVIEW OF COMPLAINT TRENDS, AND AN EVALUATION OF THE RETURNED DEVICE. THE OBTURATOR WAS NOT RECEIVED. THE TROCAR ASSEMBLY WAS RECEIVED. VISUAL INSPECTION OF THE INSTRUMENT NOTED THE CANNULA WAS HAS A CUT IN IT. THE EXPANDABLE SLEEVE HAD A CUT THAT MATCHED THE CUT ON THE CANNULA. THE CIRCULAR AND ENVELOPE SEALS WERE INTACT. THE EXPANDABLE SLEEVE WAS RECEIVED. A PMV DILATOR WAS INSERTED INTO THE TROCAR WITH NO BINDING OR DIFFICULTY. THE TROCAR/DILATOR WAS INSERTED INTO THE EXPANDABLE SLEEVE WITHOUT DIFFICULTY. THE TROCAR FAILED AN AIR LEAK TEST. THE TROCAR/DILATOR WAS INSERTED INTO THE EXPANDABLE SLEEVE WITHOUT DIFFICULTY. THE TROCAR FAILED AN AIR LEAK TEST. VISUAL AND FUNCTIONAL TESTING OF THE RETURNED SAMPLE CONFIRMED THE PRODUCT DID NOT MEET QUALITY RELEASE SPECIFICATIONS THAT WERE TESTED REGARDING THE REPORTED CONDITIONS DUE TO THE CUT CANNULA AND EXPANDABLE SLEEVE. A REVIEW OF THE DEVICE HISTORY RECORD INDICATES THIS DEVICE LOT NUMBER WAS RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. SUBSEQUENTLY, THE COMPLAINT DATA DID NOT DISPLAY AN INCREASED TREND. THERE WERE NO ADVERSE PATIENT EVENTS REPORTED AS A RESULT OF THE ALLEGED EVENT. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND REASSESSED AT THAT TIME.

    Description of Event or Problem · 1

    PROCEDURE: DIAGNOSTIC LAPAROSCOPY. ACCORDING TO THE REPORTER: THE SURGEON NOTICED A SMALL PIECE OF PLASTIC INTRA-ABDOMINAL. HE REALIZED IT BROKE OFF FROM THE TROCAR SLEEVE, AND HE REMOVED IT. THE PLASTIC PIECE ALONG WITH TROCAR SLEEVE AND MANUFACTURES LABELS WERE COLLECTED. THE SLEEVE MAY HAVE COME FROM 1 OF 2 PACKAGING (1 WITH TROCAR, CANNULA AND SLEEVE OR SEPARATELY WRAPPED SLEEVE). UNABLE TO DETERMINE WHICH PACKAGING THE PRODUCT CAME FROM, WE ARE INCLUDING INFORMATION FROM BOTH PACKAGING. THERE WAS NO HARM TO THE PATIENT. PATIENT WAS DISCHARGED SAME DAY. PRODUCT: VS101005 VERSASTEP¿ DILATOR AND CANNULA WITH RADIALLY EXPANDABLE SLEEVE 5 MM (LOT# J3L0052X) EXPIRATION: 11/30/2018, MANUFACTURING DATE: 11/01/2013 OR VERSASTEP¿ RADIALLY EXPANDABLE SLEEVE ((B)(4)) EXPIRATION: 11/30/2019, MANUFACTURING DATE: 11/01/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382354 UNKNOWN VERSASTEP LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ COVIDIEN UNKNOWN VERSAST

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR