VOLISTA
Report
- Report Number
- 9710055-2017-00064
- Event Type
- Malfunction
- Date Received
- October 18, 2017
- Report Date
- August 8, 2018
- Manufacturer
- MAQUET SAS
- Product Code
- FSY
- PMA / PMN Number
- K130513
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ME
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE FOLLOW UP REPORT IS SUBMITTED DUE TO THE MISSING F/U 3 AND IT IS SUBMITTED TO CORRECT THE ERROR IN NUMBERING. THERE IS NO NEW INFORMATION REGARDING THIS CASE. THE FINAL REPORT (F/U 7, 9710055-2017-00064 - 7) WAS SENT ON 08/08/2018. THE DATE RECEIVED BY MFG IS THE DATE WHEN THE FDA REQUEST WAS RECEIVED (02/12/2025).
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 STILL 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. (B)(4). MAQUET SAS BECAME AWARE OF AN INCIDENT WITH A SURGICAL LIGHT VOLISTA DEVICE. AS IT WAS STATED, WHEN THE SURGEON ATTEMPTED TO MANEUVER THE LIGHT BY THE HANDLE ¿ IT DETACHED AND REMAINED IN THE SURGEON'S HAND DUE TO THE PART BEING LOOSE AND UNSCREWED FROM THE DEVON ADAPTERS. THERE WAS NO PATIENT INVOLVEMENT, HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL LIGHT DID NOT MEET ITS SPECIFICATION AND IT CONTRIBUTED TO EVENT. AT THE TIME WHEN THE EVENT OCCURRED THE DEVICE WAS BEING USED FOR PATIENT TREATMENT. DURING THE INVESTIGATION IT WAS FOUND THAT THE REPORTED SCENARIO HAS NEVER LEAD TO SERIOUS INJURY OR WORSE, TO DEATH. OUR INVESTIGATION FOUND THAT -AS MENTIONED IN THE VOLISTA USER MANUAL - IT IS NECESSARY TO TURN THE HANDLE TO ADJUST THE LIGHT FIELD DIAMETER. THE DEVICE REQUIRES A SENSOR TO KNOW THE HANDLE POSITION. HOWEVER, SINCE THE MODIFICATION OF THE TILT DEVICE (FROM MECHANICAL TO ANALOGICAL SWITCH POSITION) THE ADAPTER HAS NO MECHANICAL STOP IN ROTATION. THE RESULT IS THAT THE ADAPTER CAN TURN FREELY WHICH MAKES THE TIGHTENING OF THE HANDLE INEFFICIENT AND CAN CAUSE IT COME LOOSE IF IT WAS NOT PUT ON SUFFICIENTLY. THE MANUFACTURER HAS TAKEN NOTE OF THE ISSUE AND EVALUATES FUTURE IMPROVEMENTS FOR THIS OPTIONAL FEATURE. GIVEN THE CIRCUMSTANCES AND THE FACT THAT THERE IS THE FIRST COMPLAINT 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.
THE ISSUE IS STILL 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: PEDRO CRUZ.
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 INVESTIGATION HAS BEEN FINALIZED BY THE MANUFACTURING SITE, HOWEVER THE ROOT CAUSE NEEDS TO BE CONFIRMED.
MANUFACTURER'S REFERENCE NUMBER (B)(4).
(B)(4).
REF: (B)(4).
(B)(4).
REF(B)(4).
(B)(4). EXEMPTION # E2018005. (B)(4). THE ISSUE IS STILL BEING INVESTIGATED BY THE MANUFACTURING SITE.
THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.
MAQUET MEDICAL SYSTEMS, USA SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET (B)(4), (B)(4). THE ISSUE WILL BE INVESTIGATED BY THE MANUFACTURING SITE.
REF- (B)(4).
REF - (B)(4).
ON (B)(6) 2017 MAQUET SAS BECAME AWARE OF INCIDENT WITH ONE OF SURGICAL LIGHTS- VOLISTA. AS IT WAS STATED, LIGHT HANDLES CAME UNSCREWED AND LOOSE FROM DEVON ADAPTERS AND ONE OF THEM LASTED IN SURGEON'S HAND. THERE WAS NO PATIENT INVOLVEMENT, HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 739859 | VOLISTA | LIGHT, SURGICAL, CEILING MOUNTED | FSY | MAQUET SAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |