HANAULUX 2000
Report
- Report Number
- 9710055-2019-00186
- Event Type
- Injury
- Date Received
- May 31, 2019
- Date of Event
- May 10, 2019
- Report Date
- March 19, 2020
- Manufacturer
- MAQUET SAS
- Product Code
- FTD
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET SAS, PARC DE LIMÈRE, AVENUE DE LA POMME DE PI ORLÉANS CEDEX 2, FRANCE 45074. EXEMPTION # E2018005. GETINGE USA SALES, LLC 45 BARBOUR POND DRIVE WAYNE, NJ 07470. CONTACT PERSON: (B)(4). THE ISSUE IS BEING INVESTIGATED BY MANUFACTURING SITE. H3 OTHER TEXT: DEVICE NOT RETURNED TO MANUFACTURER
GETINGE BECAME AWARE OF AN INCIDENT WITH SURGICAL LIGHT HANAULUX DEVICE. AS IT WAS STATED BY THE CUSTOMER, THERE WERE MISSING METAL PARTICLES. DESPITE THE FACT THAT THIS ISSUE WITH THE DEVICE COULD NOT BE CONFIRMED, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AND BASED ON THE POTENTIAL FOR CONTAMINATION IF THE SITUATION WAS TO REOCCUR, AS ANY OBJECT FALLING INTO THE STERILE FIELD MIGHT BE THE SOURCE OF CROSS CONTAMINATION. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL LIGHT DID MEET ITS SPECIFICATION. WHEN REVIEWING SIMILAR REPORTABLE EVENTS FOR THE SAME DEVICE, WE HAVE BEEN ABLE TO FIND ONE SIMILAR DESCRIPTION COMPARED TO THE SITUATION INVESTIGATED HERE, IN BOTH CASES THE CUSTOMER ALLEGATION COULD NOT BE CONFIRMED. THERE DOES NOT APPEAR TO BE A LINK BETWEEN THEM. WE ARE UNABLE TO STATE THE EXACT ROOT CAUSE, AS THE DEVICE WAS INSPECTED AT THE CUSTOMER SITE AND THERE WAS NO FAULT FOUND, WE CAN CONCLUDE THAT MOST LIKELY ROOT CAUSE IS USER ERROR. GETINGE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DO NOT PROPOSE ANY FURTHER ACTION AT THIS TIME.
MAQUET SAS BECAME AWARE OF AN INCIDENT WITH ONE OF SURGICAL LIGHTS- HANAULUX 2000. AS IT WAS STATED, A PIECE OF METAL WAS FOUND IN THE OPERATION ROOM AFTER BRAIN SURGERY AND THE REOPERATION WAS PERFORMED A WEEK AFTER. THE HOSPTIAL STAFF CHECKED THE SURGICAL INSTRUMENTS AND NO DEFECT WAS FOUND. ADDITIONALLY, THERE WAS NO INDICATION THIS METAL PARTICLE WOULD FALL FROM THE SURGICAL LIGHT AS IT WAS INITIALLY INSPECTED AND NO DEFECTS WERE FOUND. FROM ALL INFORMATION AVAILABLE TO DATE, WE CANNOT CONFIRM THAT A MALFUNCTION OF OUR DEVICE OCCURRED HOWEVER WE DECIDED TO REPORT THIS INCIDENT AS ADVERSE EVENT TOOK PLACE.
MANUFACTURER REFERENCE NUMBER: (B)(4).
THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.
(B)(4). EXEMPTION # E2018005. (B)(4). THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.
THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.
THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.
THE ISSUE IS STILL BEING INVESTIGATING BY THE MANUFACTURING SITE.
THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.
THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.
MANUFACTURER REFERENCE NUMBER: (B)(4).
MANUFACTURER REFERENCE NUMBER # (B)(4).
MANUFACTURER REFERENCE NUMBER # (B)(4).
MANUFACTURER REFERENCE NUMBER: (B)(4).
MANUFACTURER REFERENCE NUMBER (B)(4).
MANUFACTURER REFERENCE NUMBER # (B)(4).
MANUFACTURER REFERENCE NUMBER # (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 450897 | HANAULUX 2000 | LAMP, SURGICAL | FTD | MAQUET SAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |