X-TEN
Report
- Report Number
- 9710055-2017-00049
- Event Type
- Malfunction
- Date Received
- August 4, 2017
- Date of Event
- July 6, 2017
- Report Date
- October 5, 2018
- Manufacturer
- MAQUET SAS
- Product Code
- FSY
- PMA / PMN Number
- K040735
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE. GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF 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).
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 STIL 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 AN INCIDENT WITH A SURGICAL LIGHT XTEN DEVICE. IT WAS REPORTED BY THE CUSTOMER THAT THE LIGHT TURNED OFF DURING THE PROCEDURE WHEN THE ARM WAS BEING LOWERED BY THE PHYSICIAN . THERE WAS NO INJURY REPORTED AS A RESULT OF THIS EVENT. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL LIGHT DID NOT MEET ITS SPECIFICATION AND IT CONTRIBUTED TO EVENT. AT THE TIME OF THE INCIDENT THE DEVICE WAS BEING USED FOR PATIENT TREATMENT. DURING THE INVESTIGATION IT WAS FOUND THAT IN THE PAST THE REPORTED SCENARIO HAS NEVER LEAD TO SERIOUS INJURY OR WORSE, TO DEATH. THE DEVICE INVOLVED IN THE EVENT IS X-TEN WITH SERIAL NUMBER (B)(4). THE MANUFACTURING DATE OF THE DEVICE IS 11TH SEPTEMBER, 2007. X-TEN SURGICAL LIGHT IS DISCONTINUED SINCE FEBRUARY, 2013. PERFORMED INVESTIGATION SHOWS THAT THE ISSUE OCCURRED MOST LIKELY AS AN EFFECT OF SHORT CIRCUIT DUE TO THE CONNECTION BETWEEN WIRES GETTING LOOSE AND CAUSING AN UNDESIRED CONTACT. THIS KIND OF ISSUE COULD HAVE BEEN DETECTED BEFORE, DURING A SERVICING ACTIVITIES. UNFORTUNATELY, DUE TO THE LIMITED INFORMATION AVAILABLE REGARDING THE PREVENTIVE MAINTENANCE DONE ON THE DEVICE, WE ARE NOT ABLE TO ESTABLISH WHO AND HOW OFTEN PERFORMED THE MAINTENANCE ON THE DEVICE. HAVING IN MIND THE AGE OF THE DEVICE (OVER 10 YEARS UPON THE ISSUE OCCURRENCE) AND THE FACT THAT THIS IS A FIRST COMPLAINT REGISTERED FOR THIS SERIAL NUMBER, WE CAN LEAN TOWARDS THE CONCLUSION THAT AN ISSUE OCCURRED DUE TO THE EXCESSIVE AND PROLONGED USAGE OF THE SURGICAL LIGHT RATHER THAN ANY OTHER FACTOR. WE BELIEVE THAT ALL REMAINING DEVICES ARE PERFORMING CORRECTLY IN THE MARKET. GIVEN THE CIRCUMSTANCES AND THE FACT THAT THERE IS NO APPARENT TREND IN COMPLAINTS OF THIS NATURE WE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DO NOT PROPOSE ANY FURTHER ACTION AT THIS TIME.
MANUFACTURER REFERENCE # (B)(4).
MANUFACTURER REFERENCE # (B)(4).
MANUFACTURER REFERENCE # (B)(4).
THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.
CORRECTION: IT WAS NOTED DURING AN INTERNAL REVIEW THAT THE FACTORY DID NOT PROVIDE THE AWARE DATE - 07/07/2017 FOR THE INITIAL SUBMISSION. THE INITIAL SUBMISSION WAS SUBMITTED WITHOUT AN AWARE DATE. NOT PROVIDING THE DATE WAS AN ERROR ON THE FACTORY'S BEHALF AND THIS FOLLOW-UP MEDWATCH SERVES TO CORRECT THE ERROR. (B)(4). EXEMPTION # E2018005. (B)(4).
(B)(4). EXEMPTION # E2018005. (B)(4). THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.
THE ISSUE STILL BEING INVESTIGATED BY MANUFACTURING SITE.
ADDITIONAL INFORMATION WILL BE PROVIDED AFTER INVESTIGATION RESULT.
MANUFACTURER REFERENCE # (B)(4).
MANUFACTURER REFERENCE # (B)(4).
MANUFACTURER REFERENCE # (B)(4).
MANUFACTURER REFERENCE # (B)(4).
ON (B)(6) MAQUET (B)(4) BECAME AWARE OF AND INCIDENT WITH XTEN SURGICAL LIGHT. IT WAS REPORTED BY THE CUSTOMER THAT THE LIGHT TURN OFF DURING TH PROCEDURE WHEN THE ARM WAS BEING LOWERED . THERE WAS NO INJURY REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION ABOUT THE PATIENT WAS PROVIDED SO FAR. MANUFACTURER REFERENCE # (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 549540 | X-TEN | LIGHT, SURGICAL, CEILING MOUNTED | FSY | MAQUET SAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |