BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KOH-EFFICIENT,RUMI,3.5CM

    MDR report key: 6261240 · Received January 18, 2017

    Report

    Report Number
    1216677-2017-00001
    Event Type
    Malfunction
    Date Received
    January 18, 2017
    Date of Event
    December 22, 2016
    Report Date
    February 23, 2017
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HEW
    PMA / PMN Number
    K954311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL INC. IS CURRENTLY INVESTIGATION THE REPORTED COMPLAINT CONDITION. ONCE THE INVESTIGATION IS COMPLETED A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION. ONCE THE INVESTIGATION IS COMPLETE A FOLLOW UP REPORT WILL BE FILED. (B)(4). **UPDATE 02/23/2017: INVESTIGATION, X-INITIATED MANUFACTURER'S INVESTIGATION, NO SAMPLE RETURNED, X-REVIEW DHR, IX-NSPECT RETURNED SAMPLES, INSPECT STOCK PRODUCT. *ANALYSIS AND FINDINGS A REVIEW OF THE 2 YR COMPLAINT HISTORY REVEALS NO SIMILAR ISSUES. A DHR REVIEW OF THE RETURNED UNIT SHOWS THAT THE OCCLUDER P/N 23670-1 USED FOR THE KC-RUMI ASSEMBLY WAS PICKED FROM TWO DIFFERENT LOT, 203401 AND 203613. A QTY OF (B)(4) CAME FROM OCCLUDER LOT# 203401, AND QTY OF (B)(4) FROM LOT# 203613. THE WORK ORDER OF BOTH OF THESE OCCLUDER LOT SHOWS THAT ALL PRODUCTS WERE MANUFACTURED AND TESTED PER ESTABLISHED PROCEDURES AT CSI STAFFORD FACILITY. THE COMPLAINT DETAIL MENTIONS THAT TWO OTHER RUMI ASSEMBLIES WERE SCRAPPED, WITH 1 PC BEING RETURNED. RETURNED UNIT IS UNOPENED, AND INVESTIGATION WAS CARRIED OUT WITH IT. TO RECREATE THE ISSUE, THE ASSEMBLY WAS INFLATED WITH WATER TO DETERMINE THE EXTENT OF THE IRREGULARITY. UPON INFLATION OF 60 CC, AND SUBSEQUENTLY TO 107 CC, THERE WERE MINIMAL SIGNS OF IRREGULARITY. THE COMPLAINT CANNOT BE CONFIRMED BASED ON THE RETURNED UNIT, AS THE INFLATION OF THE BALLOON DID NOT SHOW IRREGULARITIES. THE ROOT CAUSE AS TO WHY THE BALLOON WAS IRREGULAR IS INDETERMINABLE DUE TO THE ABSENCE OF THE OBJECTIVE EVIDENCE. A CHECK IN INVENTORY TO SEE IF THERE WERE ANY MORE KC-RUMI-35, AND OCCLUDER PERTAINING TO THIS LOT DID NOT SHOW ANY MORE IN STOCK. AT THIS TIME, IT IS BELIEVED THAT THIS OCCURRENCE WAS AN ISOLATED INCIDENT, THE INCIDENT WILL BE MONITORED FOR ANY POSSIBLE TRENDING. *CORRECTIVE ACTIONS CORRECTIVE ACTION IS NOT APPLICABLE AT THIS TIME AS THE ROOT CAUSE WAS INDETERMINABLE DUE TO THE ABSENCE OF THE AFFECTED PRODUCT SAMPLE(S). ALL SEALED AND UNOPENED PRODUCT THAT WAS RETURNED PROVED TO WORK AS EXPECTED.

    Description of Event or Problem · 1

    THE BALLOONS INFLATE IRREGULARLY AND AS A RESULT THEY'VE HAD 2 VAGINAL LACERATIONS.PATIENT IS UNKNOWN, MULTIPLE FOLLOW UPS PERFORMED ON (B)(6) 2016, (B)(6) 2017. REFERENCE E-COMPLAINT-(B)(4).

    Description of Event or Problem · 1

    (B)(4). THE BALLOONS INFLATE IRREGULARLY AND AS A RESULT THEY'VE HAD 2 VAGINAL LACERATIONS. PATIENT IS UNKNOWN, MULTIPLE FOLLOW UPS PERFORMED ON (B)(6) 2016, (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43342 KOH-EFFICIENT,RUMI,3.5CM KOH-EFFICIENT,RUMI,3.5CM HEW COOPERSURGICAL, INC. KC-RUMI-35 204778

    Patients

    Seq Age Sex Outcome Treatment
    1 Other