X-TEN
Report
- Report Number
- 9710055-2018-00144
- Event Type
- Malfunction
- Date Received
- October 30, 2018
- Date of Event
- September 13, 2018
- Report Date
- June 26, 2019
- Manufacturer
- MAQUET SAS
- Product Code
- FSY
- PMA / PMN Number
- K040735
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER
Narratives
WE ARE AWARE THAT THIS IS PAST THE 30 DAY DEADLINE FOR REPORTING. WE HAVE REMINDED THE COMPLAINT HANDLER TO REVIEW FDA REPORTING GUIDELINES IN ORDER TO PREVENT THIS FROM HAPPENING AGAIN. THE ISSUE IS BEING INVESTIGATED BY MANUFACTURING SITE. 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).
MAQUET SAS BECAME AWARE OF THE ISSUE WITH ONE OF THE X-TEN SURGICAL LIGHTS. AS IT WAS STATED, A FLANGE OF SPRING ARM HAS TORN OFF. THERE IS NO INJURY REPORTED HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PART FALLING MIGHT CAUSE AN INJURY. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL LIGHT DID NOT MEET THE MANUFACTURER¿S SPECIFICATION. THERE IS NO INFORMATION PROVIDED IF DURING THE EVENT OCCURRENCE, THE DEVICE WAS OR WAS NOT BEING USED FOR PATIENT TREATMENT. DURING THIS INVESTIGATION, IT WAS ESTABLISHED THAT THE REPORTED ISSUE HAS NEVER RESULTED IN A SERIOUS INJURY OR WORSE. THE BREAKAGE APPEARED DUE TO THE TEARING OF THE SPRING ARM TUBE ON THE EDGE OF THE WELDING JOINT. THE SPRING ARM USED IN THE DEVICE IS OF PRODUCTION YEAR 2005. THE SPRING ARM DESIGN WAS ADAPTED BY INCREASING THE THICKNESS OF THE TUBE FROM 2006 PRODUCTION ONWARDS. THE OLD VERSION OF THE TUBE HAS 1,35 MM OF THICKNESS, WHEREAS THE NEW VERSION OF TUBE HAS 2,35 MM. AS A RESULT, THE EXTERNAL DIAMETER OF TUBE HAS INCREASED TO 34 MM. TO PREVENT ANY OTHER SIMILAR INCIDENT WE HAVE ADDRESSED THIS ISSUE WITH A PREVIOUS FIELD ACTION MSA-2009-003-IU[Z-0182/188-2010] AND SINCE WE SEE RECURRENCE OF THE EVENTS - AS WE RECEIVED NEW COMPLAINTS FROM CERTAIN MARKETS WHERE THESE DEVICES ARE STILL IN USE- WE STARTED A NEW FIELD ACTION MSA-2017-002-IU. THE DEVICE INVOLVED WAS CONFIRMED TO BE PART OF THE CONSIGNEE LIST AND THEREFORE WAS PLANNED TO BE UPDATED, HOWEVER THE UPDATE DID NOT TAKE PLACE YET. THE DEFECTIVE PART WAS REPLACED AFTER THE ISSUE OCCURRENCE. THE PLANNING OF THE FIELD ACTION IS DONE DEVICE PER DEVICE, BASED ON THE DEVICE AVAILABILITY: DUE TO THE FIELD ACTION ACTIVITY THE USE OF THE CUSTOMER FACILITY OR FACES DOWNTIME, WHICH IS HARD TO FIT IN OUR CUSTOMER¿S SCHEDULES. 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).
ON (B)(4) 2018 MAQUET SAS BECAME AWARE OF AN INCIDENT WITH ONE OF SURGICAL LIGHTS- X-TEN. AS STATED, A FLANGE OF SPRING ARM HAS TORN OFF. THERE IS NO INJURY REPORTED HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PART FALLING MIGHT CAUSE AN INJURY. (B)(4).
MANUFACTURER'S 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. (B)(4). EXEMPTION # E2018005. (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. (B)(4). EXEMPTION # E2018005. (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. (B)(4). EXEMPTION # E2018005. (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. (B)(4). EXEMPTION # E2018005. (B)(4).
THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE. (B)(4). EXEMPTION # E2018005. (B)(4).
MANUFACTURER'S REFERENCE NUMBER (B)(4).
MANUFACTURER'S REFERENCE NUMBER (B)(4).
MANUFACTURER'S REFERENCE NUMBER (B)(4).
MANUFACTURER'S REFERENCE NUMBER (B)(4).
MANUFACTURER'S REFERENCE NUMBER (B)(4).
MANUFACTURER'S REFERENCE NUMBER (B)(4).
MANUFACTURER'S REFERENCE NUMBER (B)(4).
MANUFACTURER'S REFERENCE NUMBER (B)(4).
MANUFACTURER'S REFERENCE NUMBER (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 861320 | X-TEN | LIGHT, SURGICAL, CEILING MOUNTED | FSY | MAQUET SAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |