BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERISEAL 27G HYDRODISSECTION VE CURVED .40MM X 22MM CANNULA

    MDR report key: 6727643 · Received July 20, 2017

    Report

    Report Number
    1836161-2017-00070
    Event Type
    Injury
    Date Received
    July 20, 2017
    Date of Event
    June 22, 2017
    Report Date
    August 23, 2017
    Manufacturer
    ASPEN SURGICAL PRODUCTS, CALEDONIA
    Product Code
    HMX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SIX SAMPLES WERE PROVIDED FROM THE USER FACILITY. SAMPLES WERE TESTED PER ISO 594-1 AND PASSED. THE CANNULAS WERE THEN ATTACHED TO A WATER FILLED SYRINGE AND PRESSURE WAS APPLIED TO THE PLUNGER. ALL SIX CANNULAS WERE TESTED MULTIPLE TIMES REPLICATE THE NEEDLE 'SHOOTING' OFF THE SYRINGE WITHOUT THE USE OF EXCESSIVE FORCE. THE FAILURE COULD NOT BE REPLICATED. THE SYRINGE THAT WAS IN USE AT THE TIME OF THE FAILURE WAS REQUESTED, BUT NOT PROVIDED. ALL SIX CANNULAS DID NOT SHOW ANY DAMAGE AND PASSED FUNCTIONAL TESTING DURING INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED ON REF 172118 THAT THE NEEDLE SHOT FROM THE LUERLOCK INTO THE EYE DURING SURGERY. NO DIRECT MATERIAL DAMAGE WAS NOTICED TO THE MATERIAL USED. THE ITEM WAS IN USE AT THE TIME OF THE ALLEGED MALFUNCTION, INJURY REPORTED. 1. WHAT IS THE CURRENT STATUS OF THE PATIENT? THE INJURY IS RESOLVED BY PERFORMING A SECOND SURGERY. 2. WHAT SURGERY/PROCEDURE WAS BEING PERFORMED? CATARACT PROCEDURE - CLOSING INCISION. 3. PLEASE DESCRIBE THE DETAILS OF THE PROCEDURE JUST PRIOR TO THE CANNULA DETACHING FROM THE LUER-LOCK SYRINGE AND DIRECTLY AFTER. DURING THE SAME PROCEDURE, BEFORE THE DETACHMENT, THE NEEDLE/SYRINGE WAS USED 3 TIMES. DURING THE PROCEDURE THE NEEDLE/SYRINGE WAS NOT SCREWED OR REFILLED. WHEN USING THE NEEDLE/SYRINGE FOR THE 4TH TIME DURING THE PROCEDURE, THE NEEDLE SHOT OF THE SYRINGE INTO THE EYE OF THE PATIENT. NO EXTREME PRESSURE WAS FELT. 4. IS THE CANNULA AND SYRINGE ROUTINELY TESTED PRIOR TO USE? DON¿T KNOW. 5. DID THE DETACHING CAUSE ANY INJURY TO THE PATIENT? IF YES, PLEASE DESCRIBE INJURY AND ANY TREATMENT PROVIDED. CAPSULAR RUPTURE AND CV BLEEDING. TREATMENT : NEW SURGERY.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ON REF 172118 THAT THE NEEDLE SHOT FROM THE LUERLOCK INTO THE EYE DURING SURGERY. NO DIRECT MATERIAL DAMAGE WAS NOTICED TO THE MATERIAL USED. THE ITEM WAS IN USE AT THE TIME OF THE ALLEGED MALFUNCTION, INJURY REPORTED. WHAT IS THE CURRENT STATUS OF THE PATIENT? THE INJURY IS RESOLVED BY PERFORMING A SECOND SURGERY. WHAT SURGERY/PROCEDURE WAS BEING PERFORMED? CATARACT PROCEDURE - CLOSING INCISION. PLEASE DESCRIBE THE DETAILS OF THE PROCEDURE JUST PRIOR TO THE CANNULA DETACHING FROM THE LUER-LOCK SYRINGE AND DIRECTLY AFTER. DURING THE SAME PROCEDURE, BEFORE THE DETACHMENT, THE NEEDLE/SYRINGE WAS USED 3 TIMES. DURING THE PROCEDURE THE NEEDLE/SYRINGE WAS NOT SCREWED OR REFILLED. WHEN USING THE NEEDLE/SYRINGE FOR THE 4TH TIME DURING THE PROCEDURE, THE NEEDLE SHOT OF THE SYRINGE INTO THE EYE OF THE PATIENT. NO EXTREME PRESSURE WAS FELT. IS THE CANNULA AND SYRINGE ROUTINELY TESTED PRIOR TO USE? DON¿T KNOW. DID THE DETACHING CAUSE ANY INJURY TO THE PATIENT? IF YES, PLEASE DESCRIBE INJURY AND ANY TREATMENT PROVIDED. CAPSULAR RUPTURE AND CV BLEEDING. TREATMENT : NEW SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507687 STERISEAL 27G HYDRODISSECTION VE CURVED .40MM X 22MM CANNULA OPHTHALMIC CANNULA HMX ASPEN SURGICAL PRODUCTS, CALEDONIA 2273D00 125519, 106197, 114028, 118525

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention