VOLISTA
Report
- Report Number
- 9710055-2019-00027
- Event Type
- Malfunction
- Date Received
- January 28, 2019
- Date of Event
- January 9, 2019
- Report Date
- August 30, 2022
- Manufacturer
- MAQUET SAS
- Product Code
- FSY
- PMA / PMN Number
- K130513
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
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 AN ISSUE WITH A SURGICAL LIGHT VOLISTA DEVICE. AS IT WAS STATED, PAINT CHIPPING OCCURRED ON FORKS OF LIGHT HEADS. THERE WAS NO INJURY REPORTED HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PAINT PARTICLE FALLING INTO THE STERILE FIELD MIGHT BE A SOURCE OF CONTAMINATION. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL LIGHT DID NOT MEET ITS SPECIFICATION AND IT CONTRIBUTED TO EVENT. NONE OF THE PROVIDED INFORMATION INDICATE THAT UPON THE EVENT OCCURRENCE 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. PEELING PAINT IS INDICATED BY OUR PRODUCT EXPERTS TO LIKELY BE CAUSED BY A STAGNATION OF AGGRESSIVE DISINFECTANT AND DETERGENT PRODUCTS DUE TO AN INAPPROPRIATE CLEANING OR DISINFECTION PROTOCOL OR BY MECHANICAL COLLISION OF THE LIGHT PARTS. THE PRODUCT VOLISTA STANDOP USER MANUAL IFU 01781 EN ED. 07 PAGES 91-94 INCLUDES AN INFORMATION TO DAILY CHECK THE DEVICE FOR CHIPPED PAINT AND ALL THE RECOMMENDED AND PROHIBITED PRODUCTS ARE LISTED. WE BELIEVE THAT ALL REMAINING DEVICES ARE PERFORMING CORRECTLY IN THE MARKET. WE ALSO BELIEVE THAT IF THE MANUFACTURER RECOMMENDATION WOULD HAVE BEEN FOLLOWED THE INCIDENT COULD HAVE BEEN AVOIDED. GIVEN THE CIRCUMSTANCES WE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DO NOT PROPOSE ANY FURTHER ACTION AT THIS TIME.
THE PURPOSE OF THIS SUBMISSION IS SOLELY TO PROVIDE A CORRECTION OF D4 CATALOG # SECTION. THIS IS BASED ON THE RESULT OF THE DEVICE HISTORY REVIEW. #D4: PREVIOUS CATALOG # : ARD567910993. CORRECTED CATALOG # : ARD568811911.
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). THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.
ON (B)(4) 2019 MAQUET (B)(4) BECAME AWARE ABOUT AN ISSUE WITH ON OF THE SURGICAL LIGHT- VOLISTA. AS IT WAS STATED, THE ARM OF THE DEVICE WAS RUSTED AND THE PAINT WAS CHIPPING FROM THE DEVICE. THERE WAS NO INJURY REPORTED , HOWEVER HAVING IN MIND SIMILAR COMPLAINTS RECEIVED IN THE PAST WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS SUCH DAMAGE IN THE PAINT INTEGRITY CAN RESULT IN PARTS FALLING INTO THE STERILE FIELD AND MIGHT BE A SOURCE OF CONTAMINATION. (B)(4).
MANUFACTURER REFERENCE NUMBER (B)(4).
MANUFACTURER REFERENCE NUMBER (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.
THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.
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. (B)(4). EXEMPTION # E2018005. (B)(4).
THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.
THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.
MANUFACTURER'S REFERENCE NUMBER: (B)(4).
MANUFACTURER'S REFERENCE NUMBER: (B)(4).
MANUFACTURER'S REFERENCE NUMBER: (B)(4).
MANUFACTURER REFERENCE NUMBER: (B)(4).
MANUFACTURER REFERENCE NUMBER: (B)(4).
MANUFACTURER'S REFERENCE NUMBER: (B)(4).
(B)(4).
MANUFACTURER 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 |
|---|---|---|---|---|---|---|---|
| 76728 | VOLISTA | LIGHT, SURGICAL, CEILING MOUNTED | FSY | MAQUET SAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |