BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GOLDMANN TONOMETER PRISM

    MDR report key: 5623928 · Received May 2, 2016

    Report

    Report Number
    1000176188-2016-00001
    Event Type
    Injury
    Date Received
    May 2, 2016
    Date of Event
    December 28, 2015
    Report Date
    April 29, 2016
    Manufacturer
    HAAG-STREIT AG
    Product Code
    HKY
    PMA / PMN Number
    NONE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WE RECEIVED A COMPLAINT ABOUT TONOMETER PRISMS FROM AN O.D. IN (B)(6) ON 28TH DECEMBER 2015. AS THERE WERE THREE CORNEAL BURNS AND PRISMS BLOATED AS DOCUMENTED AND CONVEYED TO HAAG-STREIT (B)(4). HAAG-STREIT (B)(4) PRODUCT MANAGER, (B)(4) CONTACTED (B)(4) TO DISCUSS THE CONCERNS ABOVE TO ACQUIRE FURTHER INFORMATION ABOUT THE DISINFECTION PROCESS THEY ARE UTILIZING AND THE BLOATING OF THE TONOMETER PRISMS. CURRENTLY PER HAAG-STREIT (B)(4) THE PROBLEM APPEARS TO BE ABNORMAL USE OF THE MEDICAL DEVICE PER THE INSTRUCTIONS FOR USE PROVIDED BY HAAG STREIT (B)(4). THE CURRENT SITUATION IS THE HOSPITAL SPS PERSONNEL HAVE DISINFECTED ALL OF THE TONOMETER PRISMS DUE TO CONCERNS MENTIONED ABOVE. IT APPEARS THE INSTRUCTIONS FOR USE IS NOT BEING FOLLOWED AS WRITTEN BY HAAG-STREIT (B)(4). SECONDLY, THE END USER RECENTLY HIRED 3 NEW TECHNICIANS. ADDITIONAL INFORMATION IS NEEDED AS WELL AS RETURNING THE AFFECTED MEDICAL DEVICES (TONOMETERS PRISMS) FROM (B)(6) MEDICAL CENTER OR THE (B)(6) TO HAAG-STREIT (B)(4) FOR FURTHER INVESTIGATION INTO THESE PROBLEMS. IMPORTANT INFORMATION CONCERNING THIS MEDWATCH: HAAG-STREIT USA WAS INITIALLY UNSUCCESSFUL IN SETTING UP OUR WEBTRADER ACCOUNT DUE TO CONFIGURATION ISSUES. THIS HAS TAKEN SEVERAL MONTHS TO CORRECT. WE CONTRACTED AN IT GROUP (CLEARLOGIC) TO ASSIST US TO COMPLETE THE INSTALL. WE WERE IN CONSTANT CONTACT WITH SEVERAL PEOPLE FROM THE ESG HELP DESK AND THE CDRH IN ATTEMPTS TO CORRECT THIS CONCERN THROUGH THE ENTIRE CONFIGURATION PROCESS. HAAG-STREIT USA RECEIVED APPROVAL FOR EMDR PRODUCTION TEST SUBMISSIONS AS OF 04/25/2016. IF YOU HAVE ANY QUESTIONS OR CONCERNS REGARDING THIS MEDWATCH (EMDR) PLEASE CONTACT US AND WE WILL PROVIDE ANY FURTHER INFORMATION TO ASSIST THE FDA. RESPECTFULLY, (B)(4).

    Description of Event or Problem · 1

    WE HAVE RECENTLY BEEN FORCED TO HAVE OUR HOSPITAL'S STERILE PROCESSING SERVICE (SPS) DISINFECT ALL OF OUR TONOMETER PRISMS. FOR A WHILE THEY WERE FOLLOWING YOUR RECOMMENDED SODIUM HYPOCHLORITE PROTOCOL, BUT THEY JUST HIRED THREE NEW TECHNICIANS. WE NOW HAVE PRODUCED THREE CORNEAL BURNS AND HAVE FREQUENTLY REJECTED PRISMS THAT HAD A RESIDUE ON THE OCULAR SURFACE. IF THAT WASN'T BAD ENOUGH, WE NOW HAVE MORE THAN 11 PRISMS THAT WILL NO LONGER FIT INTO THE RETAINING RING ON THE TONOMETER ARM. THEY ARE BLOATED. I HAVE ASKED SPS IF THEY WERE AUTOCLAVING THE PRISMS; THEY HAVE DENIED THE USE OF STEAM. SO, WHAT ELSE COULD CAUSE THIS EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278924 GOLDMANN TONOMETER PRISM TONOMETER PRISM (21 CFR 886.1930) HKY HAAG-STREIT AG NONE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other