BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISP FIRSTPASS STR PASSR SELF

    MDR report key: 10009687 · Received April 29, 2020

    Report

    Report Number
    3006524618-2020-00223
    Event Type
    Injury
    Date Received
    April 29, 2020
    Date of Event
    April 8, 2020
    Report Date
    June 15, 2020
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    HWQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DISPOSABLE FIRSTPASS SUTURE PASSER DEVICE, USED IN TREATMENT, WAS RETURNED FOR EVALUATION. A RELATIONSHIP BETWEEN THE DEVICE AND REPORTED INCIDENT WAS ESTABLISHED. A REVIEW OF MANUFACTURING RECORDS FOR THE REPORTED LOT NUMBER 2040498 FOUND NO NON-CONFORMANCES OR ANOMALIES DURING MANUFACTURING PROCESS RELATED TO THE REPORTED EVENT. A COMPLAINT HISTORY REVIEW FOUND NO RELATED FAILURES; THIS FAILURE MODE WILL BE TRENDED TO ASSESS FOR ANY NECESSARY CORRECTIVE ACTIONS. REVIEW OF THE PRODUCT INSTRUCTIONS FOR USE FOUND ADEQUATE WARNINGS AND PRECAUTIONS TO PREVENT DAMAGE TO THE DEVICE DURING USE. RISK MANAGEMENT DOCUMENTS WERE REVIEWED FINDING NO ADDITIONAL RISKS THAT REQUIRE TO BE ADDED TO THE REFERENCE DOCUMENT. VISUAL INSPECTION SHOWS NO MANUFACTURING ABNORMALITIES ON THE DEVICE. THE SUTURE CAPTURE IS MISSING. DURING FUNCTIONAL EVALUATION THE FIRST STEP OF THE TRIGGER PERFORMED AS SPECIFIED; PRESSING THE LEVER THE NEEDLE WAS EXTRACTED AS INTENDED; A FURTHER TEST WAS MADE BY USING AN ULTRATAPE (COBRAID BLUE 38¿); THE NEEDLE CAPTURED THE SUTURE AS INTENDED BUT THE SUTURE CAPTURE ON THE TOP BRACKET FOR HOLDING BACK THE SUTURE IS MISSING. THE COMPLAINT WAS VERIFIED. AN EXACT ROOT CAUSE CANNOT BE DETERMINED WITH CONFIDENCE; HOWEVER, POTENTIAL FACTORS UNRELATED TO THE DESIGN OR MANUFACTURE OF THE DEVICE THAT MAY LEAD TO THE FAILURE REPORTED INCLUDE, BUT ARE NOT LIMITED TO: (1) EXCESSIVE FORCE (2) DAMAGE TIP OR DEBRIS BETWEEN PASSES (3) TISSUE THICKNESS. THERE WERE NO INDICATIONS THAT WOULD SUGGEST THAT THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. MIMB REVIEW. ASSESS SEVERITY OF COMPLAINT CASE TO DETERMINE IF ADDITIONAL ACTIONS OR INPUTS ARE REQUIRED FOR INCLUSION IN THE MEDICAL ASSESSMENT. DETERMINE IF A MEDICAL ASSESSMENT WILL BE PERFORMED BASED ON A REVIEW OF THE COMPLAINT DETAILS AND FURTHER INPUT FROM THE MEDICAL DIRECTOR/DESIGNEE. MIMB CLOSURE - REVIEWED DURING MIMB. A MEDICAL INVESTIGATION WILL BE PERFORMED. PROCEED BASED ON INFORMATION PROVIDED/AVAILABLE FOR THE INVESTIGATION; IF NO RELEVANT CLINICAL INFORMATION IS PROVIDED, RECOMMEND CLOSURE. APPROVED BY DR. (B)(6), MEDICAL DIRECTOR A REVIEW OF RELEVANT CLINICAL/MEDICAL INFORMATION IN THE REPORTED ISSUE, INCLUSIVE OF TECHNIQUE AND PATIENT INFORMATION, TO INCLUDE, BUT NOT LIMITED TO: PATIENT INFORMATION ,SURGICAL PROCEDURE/POST-OPERATIVE CARE REVIEW ,DEVICE LABELING (INCLUDING TECHNIQUE GUIDES, IFUS, ETC.) THIS COMPLAINT FROM JAPAN REPORTS, ¿THAT DURING THE SURGERY THE SUTURE CAPTURE PART OF THE SUTURE PASSER BROKE OFF. NO PATIENT INJURIES OR SIGNIFICANT DELAY REPORTED. BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY.¿ NO CLINICAL/MEDICAL DOCUMENTATION WAS PROVIDED FOR THIS INVESTIGATION. WITHOUT SUPPORTING CLINICAL/MEDICAL DOCUMENTS, A THOROUGH INVESTIGATION CANNOT BE PERFORMED. PER THE INTAKE TEAM; ALL EFFORTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS COMPLAINT DID NOT PROVIDE ANY RESULTS. IF ADDITIONAL SUPPORTING MEDICAL DOCUMENTS ARE RECEIVED THIS COMPLAINT WILL BE REASSESSED.

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE SURGERY THE SUTURE CAPTURE PART OF THE SUTURE PASSER BROKE OFF. NO PATIENT INJURIES OR SIGNIFICANT DELAY REPORTED. BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474347 DISP FIRSTPASS STR PASSR SELF PASSER HWQ ARTHROCARE CORP. 22-4038 2040498

    Patients

    Seq Age Sex Outcome Treatment
    1 Other