LUCEA 10

Description of Event or Problem

ON (B)(6) 2022, GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF EXAMINATION LIGHTS - LUCEA 10. IT WAS NOT POSSIBLE TO DETERMINE IF THE ISSUE SHOULD BE REPORTED. ON 26TH MAY TECHNICIAN PROVIDED ADDITIONAL INFORMATION ABOUT REPORTABLE ISSUE WITH THE PICTURES ATTACHED. IT WAS STATED THE HEADLIGHT COVER WAS CRACKED WITH MISSING PARTICLES AND DETACHED DUE TO IMPACT. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY DETACHMENT OF PART OR PARTICLES MAY LEAD TO POTENTIAL INFECTION OF THE PATIENT.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. DEVICE NOT RETURNED TO MANUFACTURER.

Additional Manufacturer Narrative

GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF EXAMINATION LIGHTS - LUCEA 10. IT WAS NOT POSSIBLE TO DETERMINE IF THE ISSUE SHOULD BE REPORTED. ON 26TH MAY TECHNICIAN PROVIDED ADDITIONAL INFORMATION ABOUT REPORTABLE ISSUE WITH THE PICTURES ATTACHED. IT WAS STATED THE HEADLIGHT COVER WAS CRACKED WITH MISSING PARTICLES AND DETACHED DUE TO IMPACT. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY DETACHMENT OF PART OR PARTICLES MAY LEAD TO POTENTIAL INFECTION OF THE PATIENT. THE DEVICE WAS REPAIRED BY REPLACEMENT OF TWO COMPONENTS: HANDLE INTERFACE (ARD368606997) AND TRANSPARENT PLASTIC COVER (ARD36801555). BASED ON THE INFORMATION COLLECTED, IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, SURGICAL LIGHTS DID NOT MEET THEIR SPECIFICATION, SINCE CRACKS IN COVERS, RESULTING IN MISSING PLASTIC PARTICLES OR DETACHMENT OF THE COVER COULD BE CONSIDERED AS A TECHNICAL DEFICIENCY, AND IN THIS WAY THE DEVICE CONTRIBUTED TO THE EVENT. THE PROVIDED INFORMATION DOES NOT INDICATE IF UPON THE EVENT OCCURRENCE, THE DEVICE WAS OR WAS NOT BEING USED FOR PATIENT TREATMENT. WHEN REVIEWING REPORTABLE EVENTS FOR THIS TYPE OF ISSUE WE WERE ABLE TO ESTABLISH THAT THE RECEIVED INCIDENTS ARE OCCURRING AT MODERATE RATIO FOR THE BROKEN COVERS. WE HAVE BEEN ABLE TO CONFIRM THAT THE INVESTIGATED ISSUE HAS NEVER LED TO SERIOUS INJURY OR WORSE, TO OUR KNOWLEDGE. AS PER EXPERTISE PERFORMED BY THE SUBJECT MATTER EXPERT AT MANUFACTURING SITE THE CRACKS DETECTED ON THE HANDLE INTERFACE AND TRANSPARENT COVER FIXING POINTS WERE PROBABLY CAUSED BY IMPROPER USE, COLLISIONS, INCOMPATIBLE CLEANING PRODUCTS OR PROTOCOL. TO PREVENT ANY INCIDENT THE USER MANUAL FOR LUCEA 10/40 (IFU 01701 EN 11) ON PAGE 21 MENTIONS TO CHECK THE INTEGRITY OF THE LIGHT HEADS DURING DAILY INSPECTION. FURTHERMORE, THE SAME USER MANUAL ON PAGES 28-29 EXPLAINS HOW TO CLEAN AND DISINFECT THE LIGHT HEADS. THIS DOCUMENT INCLUDES SOME RECOMMENDED PRODUCTS AND SOME PROHIBITED PRODUCTS. IN ORDER TO AVOID TORQUES APPLIED ON THE TRANSPARENT HOUSING DURING USE THE USER MANUAL FOR LUCEA 10/40 (IFU 01701 EN 11) ON PAGE 24 MENTIONS TO HANDLE THE LIGHT HEAD BY THE HANDLE. WE BELIEVE THE RELATED DEVICES ARE PERFORMING CORRECTLY IN THE MARKET. WE ALSO BELIEVE THAT IF THE MANUFACTURER¿S RECOMMENDATION HAD BEEN FOLLOWED THE INCIDENT COULD HAVE BEEN AVOIDED. GETINGE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DO NOT PROPOSE ANY FURTHER ACTION AT THIS TIME.

Description of Event or Problem

MANUFACTURER'S REFERENCE NUMBER (B)(4).