GE 15
Report
- Report Number
- 9616031-2019-00009
- Event Type
- Malfunction
- Date Received
- March 21, 2019
- Report Date
- February 11, 2020
- Manufacturer
- GETINGE DISINFECTION AB
- Product Code
- MEC
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
THIS REPORT IS BEING FILED UNDER EXEMPTION E2017050 BY THE MANUFACTURER GETINGE DISINFECTION AB, (REGISTRATION NO. 9616031) ON BEHALF OF THE IMPORTER GETINGE GROUP LOGISTICS AMERICA, LLC (REGISTRATION NO. 3012092534). THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.
THIS REPORT IS BEING FILED UNDER EXEMPTION E2017050 BY THE MANUFACTURER GETINGE DISINFECTION AB, (REGISTRATION NO. 9616031) ON BEHALF OF THE IMPORTER GETINGE GROUP LOGISTICS AMERICA, LLC (REGISTRATION NO. 3012092534). THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.
WHEN REVIEWING REPORTABLE EVENTS FOR THIS TYPE OF ISSUES WE WERE ABLE TO ESTABLISH THAT RECEIVED INCIDENT IS THE FIRST ONE REGISTERED IN GETINGE COMPLAINT HANDLING SYSTEMS FOR ISSUES WITH GREEN PARTICLES RELEASE FROM A [?]TRAYPAD' WHICH IS USED AS AN ACCESSORY FOR WASHER DISINFECTORS MANUFACTURED BY GETINGE DISINFECTION AB. ON 13TH MARCH, 2019 WE BECAME AWARE OF AN ISSUE WITH WD15 CLARO WASHER-DISINFECTOR. AS IT WAS STATED, THE FILTER MATERIAL OF UPPER SCREEN, WHICH IS USED TO PLACE THE INSTRUMENTS ON IT, RELEASED GREEN PARTICLES WHICH WERE FOUND ON THE INSTRUMENTS AND CONSEQUENTLY IN THE PATIENT'S EYE DURING THE PROCEDURE. THE PARTICLES WERE REMOVED FROM THE EYE BY THE OPHTHALMOLOGIST USING A SUCTION DEVICE AND WE DID NOT RECEIVE ANY INFORMATION REGARDING ADVERSE OUTCOME OF THIS EVENT. THE WASHER-DISINFECTOR WD15 IS NOT SOLD ON THE US MARKET HOWEVER THIS PARTICULAR ACCESSORY (SPRI 2 SCREEN) COULD BE SOLD TOGETHER WITH DEVICES MARKETED IN US AS WASHER-DISINFECTORS. WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL AS FOREIGN PARTICLES OCCURRENCE IN PATIENT'S BODY MAY LEAD TO THE COMPLICATIONS. WHEN THE EVENT OCCURRED, THE DEVICE DID NOT MEET ITS SPECIFICATION AND IT CONTRIBUTED TO EVENT. UPON THE EVENT OCCURRENCE THE DEVICE WAS NOT BEING USED FOR PATIENT TREATMENT. DUE TO THE LIMITATIONS OF THE INFORMATION RECEIVED AND INFORMATION THAT HAS COME FORWARD FROM INSPECTION OF THE ACCESSORY AS PART OF SUBJECT MATTER EXPERT INVESTIGATION, WE HAVE NOT BEEN ABLE TO COME TO A ROOT CAUSE CONCLUSION WITH ANY ACCEPTABLE DEGREE OF CERTAINTY. BASED ON THE INFORMATION COLLECTED TO DATE AND AS A RESULT OF THE PERFORMED INVESTIGATION IT HAS BEEN FOUND LIKELY THAT THE ISSUE OCCURRENCE IS CAUSED BY REUSE OF SINGLE USE PART. WE CURRENTLY DO NOT HAVE ANY INFORMATION THAT WOULD WARRANT FURTHER ACTION TOWARDS THE DEVICE MANUFACTURING OR DEVICES ON THE MARKET, HOWEVER AS PER OUR COMPLAINT HANDLING PROCESSES WILL CONTINUE TO MONITOR THE CUSTOMER EXPERIENCES WITH THE DEVICE FOR ANY FUTURE INFORMATION.
THE ISSUE IS BEING INVESTIGATED BY MANUFACTURING SITE.
THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.
THIS REPORT IS BEING FILED UNDER EXEMPTION E2017050 BY THE MANUFACTURER GETINGE DISINFECTION AB, (REGISTRATION NO. 9616031) ON BEHALF OF THE IMPORTER GETINGE GROUP LOGISTICS AMERICA, LLC (REGISTRATION NO. 3012092534). THE ISSUE IS BEING INVESTIGATED BY MANUFACTURING SITE.
THE ISSUE IS BEING INVESTIGATED BY MANUFACTURING SITE.
THIS REPORT IS BEING FILED UNDER EXEMPTION E2017050 BY THE MANUFACTURER GETINGE DISINFECTION AB, (REGISTRATION NO. 9616031) ON BEHALF OF THE IMPORTER GETINGE GROUP LOGISTICS AMERICA, LLC (REGISTRATION NO. 3012092534). THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.
CORRECTION IS BEING SENT AS PREVIOUS MANUFACTURER NARRATIVE DID NOT REFLECT FULLY THE ROOT CAUSE OF THIS PARTICULAR ISSUE. WHEN REVIEWING REPORTABLE EVENTS FOR THIS TYPE OF ISSUES WE WERE ABLE TO ESTABLISH THAT RECEIVED INCIDENT IS THE FIRST ONE REGISTERED IN GETINGE COMPLAINT HANDLING SYSTEMS FOR ISSUES WITH GREEN PARTICLES BECOMING RELEASED FROM A [?]TRAYPAD' WHICH IS USED AS AN ACCESSORY FOR WASHER DISINFECTORS MANUFACTURED BY GETINGE DISINFECTION AB. ON 13TH MARCH, 2019 WE BECAME AWARE OF AN ISSUE WITH WD15 CLARO WASHER-DISINFECTOR. AS IT WAS STATED, THE FILTER MATERIAL OF THE UPPER SCREEN, WHICH IS USED TO PLACE THE INSTRUMENTS ON IT, RELEASED GREEN PARTICLES WHICH WERE FOUND ON THE INSTRUMENTS AND CONSEQUENTLY IN THE PATIENT'S EYE DURING THE PROCEDURE. THE PARTICLES WERE REMOVED FROM THE EYE BY THE OPHTHALMOLOGIST USING A SUCTION DEVICE AND WE DID NOT RECEIVE ANY INFORMATION REGARDING ANY FURTHER ADVERSE OUTCOME OF THIS EVENT. THE WASHER-DISINFECTOR WD15 IS NOT SOLD ON THE US MARKET HOWEVER THIS PARTICULAR ACCESSORY (SPRI 2 SCREEN) COULD BE SOLD TOGETHER WITH DEVICES MARKETED IN US AS WASHER-DISINFECTORS. WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL AS FOREIGN PARTICLES IN THE PATIENT'S EYE MAY LEAD TO THE COMPLICATIONS. WHEN THE EVENT OCCURRED, THE DEVICE DID NOT MEET ITS SPECIFICATION AND IT CONTRIBUTED TO THE EVENT. UPON THE EVENT OCCURRENCE THE DEVICE WAS NOT BEING USED FOR PATIENT TREATMENT. DESPITE OUR BEST EFFORTS WE FACE SOME LIMITATIONS WITH REGARDS TO THE COMPLAINT INFORMATION RECEIVED. IT IS NOT CLEAR HOW THE INSTRUMENTS USED ON THE PATIENT'S EYE WERE WASHED. IT IS CLEARLY STATED IN THE INSTRUCTIONS FOR USE THAT THE OPERATOR OF THE WASHER-DISINFECTOR NEEDS TO CHECK ALL INSTRUMENTS AFTER WASHING PROCESS. INFORMATION THAT HAS COME FORWARD FROM INSPECTION OF THE ACCESSORY AS PART OF SUBJECT MATTER EXPERT INVESTIGATION, HAS NOT ENABLED US TO COME TO A ROOT CAUSE CONCLUSION WITH ANY ACCEPTABLE DEGREE OF CERTAINTY. TO DATE IT HAS COME FORWARD THAT IT IS BY NO MEANS SURE THAT THIS MATERIAL COMES FROM THE "TRAYPAD" COVER, AS IT WAS ALLEGED, OR FROM ANYTHING ELSE. WHAT IS CLEAR HOWEVER IS THAT THIS "TRAYPAD" IS NOT INTENDED TO BE USED WITH THE WD15 DEVICE. WE CURRENTLY DO NOT HAVE ANY INFORMATION THAT WOULD WARRANT FURTHER ACTION TOWARDS THE DEVICE MANUFACTURING OR DEVICES ON THE MARKET, HOWEVER AS PER OUR COMPLAINT HANDLING PROCESSES WILL CONTINUE TO MONITOR THE CUSTOMER EXPERIENCES WITH THE DEVICE FOR ANY FUTURE INFORMATION.
THIS REPORT IS BEING FILED UNDER EXEMPTION E2017050 BY THE MANUFACTURER GETINGE DISINFECTION AB, (REGISTRATION NO. 9616031) ON BEHALF OF THE IMPORTER GETINGE GROUP LOGISTICS AMERICA, LLC (REGISTRATION NO. 3012092534). THE ISSUE IS BEING INVESTIGATED BY MANUFACTURING SITE.
THE ISSUE IS BEING INVESTIGATED BY MANUFACTURING SITE.
THE ISSUE IS BEING INVESTIGATED BY MANUFACTURING SITE.
THE ISSUE IS BEING INVESTIGATED BY MANUFACTURING SITE.
ON (B)(6) 2019 WE BECAME AWARE OF AN ISSUE WITH WD15 CLARO WASHER-DISINFECTOR. AS IT WAS STATED, THE FILTER MATERIAL OF UPPER SCREEN, WHICH IS USED TO PLACE THE INSTRUMENTS ON IT, UNLEASHED GREEN PARTICLES WHICH WERE FOUND ON THE INSTRUMENTS AND CONSEQUENTLY IN PATIENT'S EYE DURING THE PROCEDURE. THE PARTICLES WERE REMOVED FROM AN EYE BY THE OPHTHALMOLOGIST USING A SUCTION DEVICE AND SO FAR WE DID NOT RECEIVE ANY INFORMATION REGARDING ADVERSE OUTCOME OF THIS EVENT. THE WASHER-DISINFECTOR WD15 IS NOT SOLD ON THE US MARKET HOWEVER THIS PARTICULAR ACCESSORY (SPRI 2 SCREEN) COULD BE SOLD TOGETHER WITH DEVICES MARKETED IN US IN WASHER-DISINFECTORS. WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL AS FOREIGN PARTICLES OCCURRENCE IN PATIENT'S BODY MAY LEAD TO THE CONTAMINATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 233299 | GE 15 | WD 15 CLARO | MEC | GETINGE DISINFECTION AB | GE 15 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |