BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CTS22, 12X100 KII SLEEVE ZTHR 12/BX

    MDR report key: 8117446 · Received November 29, 2018

    Report

    Report Number
    2027111-2018-00448
    Event Type
    Malfunction
    Date Received
    November 29, 2018
    Date of Event
    September 14, 2018
    Report Date
    December 14, 2018
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GCJ
    UDI-DI
    00607915123734
    PMA / PMN Number
    K060096
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT UNIT WAS RETURNED TO APPLIED MEDICAL FOR EVALUATION. VISUAL INSPECTION CONFIRMED THE COMPLAINANT'S EXPERIENCE OF A DAMAGED CANNULA TIP. AT THIS TIME, APPLIED MEDICAL IS UNABLE TO DETERMINE THE ROOT CAUSE OF THE DAMAGED CANNULA TIP. APPLIED MEDICAL WILL CONTINUE TO MONITOR ITS VIGILANCE SYSTEM FOR TRENDS AND TAKE APPROPRIATE ACTIONS, AS NECESSARY, TO ENSURE THE PERFORMANCE AND SAFETY OF ITS PRODUCTS.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: LAPAROSCOPIC CHOLECYSTECTOMY CER#: (B)(4) WILL ADDRESS EVENT DEVICE 1 OF 2. CER#:(B)(4) WILL ADDRESS EVENT DEVICE 2 OF 2. EVENT DESCRIPTION: THE DOCTOR REPORTED TWO INCIDENTS OF THE SLEEVE TIP BENDING. THE DOCTOR REPORTED HAVING TROUBLE WHILE TRYING TO INTRODUCE THE TROCAR. THE TIP OF THE SLEEVE BENT. THE DOCTOR TRIED TO REPAIR THE BEND UNSUCCESSFULLY. THE SLEEVE WAS REPLACED AND THE SAME THING OCCURRED. THE DOCTOR HAS USED THE DEVICES BEFORE AND WAS NOT NEW TO THE DEVICE. THE REP WAS NOT PRESENT DURING THE CASE. THE OBTURATOR WAS INSIDE WHILE THE DOCTOR TRIED TO INTRODUCE THE TROCAR. NO INJURY OCCURRED. THE PATIENT IS 36 YEARS OLD. BOTH DEVICES ARE AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 21SEP2018 FROM REGULATORY AFFAIRS: AT THE UMBILICUS PORT I TRIED TO INTRODUCE THE TROCAR MORE THAN ONCE, WHEN I NOTICED THE TIP OF THE TROCAR WAS BEND OR IRREGULAR. I TRIED A SECOND ONE AND HAPPENED THE SAME THING. I HAD TO CUT THE APONEUROSIS WITH HASSON TECHNIQUE. THE SURGEON DID MENTIONED HE TRIED TO UNBEND THE SLEEVE WITH TWEEZERS (KELLY OR SIMILAR) IN THE OR. ADDITIONAL INSTRUMENTS USED WERE LAPAROSCOPIC INSTRUMENTS. PATIENT STATUS: HEALTHY.

    Additional Manufacturer Narrative · 1

    THE EVENT UNIT HAS BEEN RETURNED TO APPLIED MEDICAL FOR EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 1

    PROCEDURE PERFORMED: LAPAROSCOPIC CHOLECYSTECTOMY. CER # 2018-100565 WILL ADDRESS EVENT DEVICE 1 OF 2. CER # 2018-100566 WILL ADDRESS EVENT DEVICE 2 OF 2. EVENT DESCRIPTION: THE DOCTOR REPORTED TWO INCIDENTS OF THE SLEEVE TIP BENDING. THE DOCTOR REPORTED HAVING TROUBLE WHILE TRYING TO INTRODUCE THE TROCAR. THE TIP OF THE SLEEVE BENT. THE DOCTOR TRIED TO REPAIR THE BEND UNSUCCESSFULLY. THE SLEEVE WAS REPLACED AND THE SAME THING OCCURRED. THE DOCTOR HAS USED THE DEVICES BEFORE AND WAS NOT NEW TO THE DEVICE. THE REP WAS NOT PRESENT DURING THE CASE. THE OBTURATOR WAS INSIDE WHILE THE DOCTOR TRIED TO INTRODUCE THE TROCAR. NO INJURY OCCURRED. THE PATIENT IS (B)(6). BOTH DEVICES ARE AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 21SEP2018 FROM REGULATORY AFFAIRS. AT THE UMBILICUS PORT I TRIED TO INTRODUCE THE TROCAR MORE THAN ONCE, WHEN I NOTICED THE TIPO OF THE TROCAR WAS BEND OR IRREGULAR. I TRIED A SECOND ONE AND HAPPENED THE SAME THING. I HAD TO CUT THE APONEUROSIS WITH HASSON TECHNIQUE. THE SURGEON DID MENTIONED HE TRIED TO UNBEND THE SLEEVE WITH TWEEZERS (KELLY OR SIMILAR) IN THE OR. ADDITIONAL INSTRUMENTS USED WERE LAPAROSCOPIC INSTRUMENTS. PATIENT STATUS: HEALTHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    956685 CTS22, 12X100 KII SLEEVE ZTHR 12/BX GCJ GCJ APPLIED MEDICAL RESOURCES CTS22 1327156 00607915123734

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR LAPAROSCOPIC INSTRUMENTS