BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C-T II PORT CLOSURE,10/15

    MDR report key: 9111340 · Received September 24, 2019

    Report

    Report Number
    1216677-2019-00261
    Event Type
    Malfunction
    Date Received
    September 24, 2019
    Date of Event
    August 26, 2019
    Report Date
    May 7, 2020
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GCJ
    PMA / PMN Number
    K980123
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE: E-COMPLAINT: (B)(4). INVESTIGATION: X-INITIATED MANUFACTURER'S INVESTIGATION: X-REVIEW DHR. ANALYSIS AND FINDINGS: DISTRIBUTION HISTORY: THE COMPLAINT PRODUCT WAS PACKAGED AT CSI, TRUMBULL FROM 4/5/2019 - 4/12/2019 UNDER WORK ORDER: (B)(4). MANUFACTURING RECORD REVIEW: DHR 253262 WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. INCOMING INSPECTION REVIEW: INCOMING INSPECTION WAS REVIEWED FOR THE INDICATED 15MM SUTURE GUIDE, PART NUMBER: 53478, LOTS: 70971, 71333 AND 71420, NO NONCONFORMITIES WERE REPORTED. IT SHOULD BE NOTED THAT EACH DEVICE IS FUNCTIONALLY VERIFIED 100% BY THE OEM BEFORE SHIPPING TO CSI AND SAMPLED AT IQC INSPECTION. SERVICE HISTORY RECORD: SERVICE HISTORY NOT APPLICABLE FOR THIS PRODUCT. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE ATTACHED 2-YEAR COMPLAINT HISTORY DID SHOW SIMILAR REPORTED COMPLAINT CONDITIONS. PRODUCT RECEIPT: THE COMPLAINT PRODUCT WAS RECEIVED AND NOTED IN DATAWORKS AS 09/20/2019. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT PRODUCT WAS NOT ABLE TO BE PERFORMED AS THE SAMPLE WAS NOT AVAILABLE AT THE TIME OF THIS INVESTIGATION. SHOULD THE SAMPLE BE MADE AVAILABLE IN THE FUTURE, THE COMPLAINT MAY BE REOPENED AND ADDRESSED AS NEEDED. FUNCTIONAL EVALUATION: FUNCTIONAL EXAMINATION OF THE COMPLAINT PRODUCT WAS NOT ABLE TO BE PERFORMED AS THE SAMPLE WAS NOT AVAILABLE AT THE TIME OF THIS INVESTIGATION. SHOULD THE SAMPLE BE MADE AVAILABLE IN THE FUTURE, THE COMPLAINT MAY BE REOPENED AND ADDRESSED AS NEEDED. ROOT CAUSE. ROOT CAUSE IS CONSIDERED INDETERMINABLE AS THE SAMPLE WAS NOT AVAILABLE AT THE TIME OF THIS INVESTIGATION. HOWEVER, SHOULD THE SAMPLE BE MADE AVAILABLE IN THE FUTURE, THE COMPLAINT MAY BE REOPENED AND ADDRESSED AS NEEDED. CORRECTION AND/OR CORRECTIVE ACTION: COOPERSURGICAL WILL CONTINUE TO TREND THIS COMPLAINT CONDITION. NO FURTHER CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    PER REPORT: "TOWARDS THE END OF THE SURGICAL PROCEDURE, AS THE SURGICAL WAS TRYING TO CLOSE THE TROCAR OPENING THE TIP OF THE CARTER THOMPSON (15MM SUTURE GUIDE) BROKE OFF INTO THE FASCIA OF THE PATIENT. THERE WAS NO HARM TO THE PATIENT. THE WAY THIS ITEM IS USED, THERE SOME FORCE THAT HAS TO BE APPLIED IN ORDER TO LOCATE THE TROCAR OPENING TO CLOSE. IT WAS DURING THIS MANEUVERING THAT THE SUTURE GUIDE BROKE AND DETACHED. THE LOOSE PIECE WAS LOCATED AND THEN THE TROCAR HOLE WAS CLOSED BY SUTURE. THE PROCEDURE ENDED WITH NO INJURY TO THE PATIENT. ALL ITEMS WERE LOCATED IDENTIFIED AND BAGGED. THIS SYSTEM COMES WITH 1 SUTURE PASSER AND 2 SUTURE GUIDES (10-12MM, 15MM). IT WAS THE 15MM SUTURE GUIDE THAT BROKE OFF WHEN USING IT WITH THE SUTURE PASSER." REF: E-COMPLAINT: (B)(4).

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL, INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION. ONCE THE INVESTIGATION IS COMPLETED A FOLLOW UP REPORT WILL BE FILED. REFERENCE: E-COMPLAINT (B)(4).

    Description of Event or Problem · 1

    PER REPORT- "TOWARDS THE END OF THE SURGICAL PROCEDURE, AS THE SURGICAL WAS TRYING TO CLOSE THE TROCAR OPENING THE TIP OF THE CARTER THOMPSON (15MM SUTURE GUIDE) BROKE OFF INTO THE FASCIA OF THE PATIENT. THERE WAS NO HARM TO THE PATIENT. THE WAY THIS ITEM IS USED, THERE SOME FORCE THAT HAS TO BE APPLIED IN ORDER TO LOCATE THE TROCAR OPENING TO CLOSE. IT WAS DURING THIS MANEUVERING THAT THE SUTURE GUIDE BROKE AND DETACHED. THE LOOSE PIECE WAS LOCATED AND THEN THE TROCAR HOLE WAS CLOSED BY SUTURE. THE PROCEDURE ENDED WITH NO INJURY TO THE PATIENT. ALL ITEMS WERE LOCATED IDENTIFIED AND BAGGED. THIS SYSTEM COMES WITH 1 SUTURE PASSER AND 2 SUTURE GUIDES (10-12MM, 15MM). IT WAS THE 15MM SUTURE GUIDE THAT BROKE OFF WHEN USING IT WITH THE SUTURE PASSER." REF: E-COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    907892 C-T II PORT CLOSURE,10/15 C-T CLOSESURE GCJ COOPERSURGICAL, INC. CTI-1015P 253262

    Patients

    Seq Age Sex Outcome Treatment
    1 Other