VOLISTA STANDOP
Report
- Report Number
- 9710055-2019-00196
- Event Type
- Malfunction
- Date Received
- June 12, 2019
- Date of Event
- June 5, 2019
- Report Date
- February 5, 2020
- Manufacturer
- MAQUET SAS
- Product Code
- FSY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
GETINGE BECAME AWARE OF A CUSTOMER¿S PROBLEM WITH THE VOLISTA DEVICE. AS IT WAS STATED IN THE CUSTOMER PRODUCT COMPLAINT, CHIPPING PAINT WAS OBSERVED. THERE WAS NO INJURY TO A PATIENT REPORTED, HOWEVER IT WAS DECIDED TO REPORT THIS ISSUE BASED ON THE POTENTIAL AND IN ABUNDANCE OF CAUTION, AS ANY PARTICLE FALLING FROM THE DEVICE 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 THE EVENT. THE PROVIDED INFORMATION DID NOT INDICATE THAT THE DEVICE WAS BEING USED FOR PATIENT TREATMENT WHEN THE EVENT TOOK PLACE. DURING THE INVESTIGATION IT WAS FOUND THAT IN THE PAST THE REPORTED SCENARIO HAS NEVER LED TO SERIOUS INJURY, NOR DEATH. THE SUBJECT MATTER EXPERTS AT THE MANUFACTURING SITE POINT OUT THAT CHIPPING PAINT IS MOST LIKELY CAUSED BY IMPROPER CLEANING METHODOLOGY. THE USER MANUAL SHIPPED WITH EACH DEVICE INDICATES HOW TO CORRECTLY PERFORM CLEANING PROCEDURE AND INFORMATION TO CHECK THE DEVICE MONTHLY IN ORDER TO DETECT PAINT DEFECTS. WE BELIEVE THAT ALL REMAINING DEVICES ARE PERFORMING CORRECTLY IN THE MARKET, AND THAT IF THE MANUFACTURER RECOMMENDATIONS WOULD HAVE BEEN FOLLOWED THE INCIDENT COULD HAVE BEEN AVOIDED. 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.
THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.
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). H3 OTHER TEXT: DEVICE NOT RETURNED TO THE MANUFACTURER.
MANUFACTURER REFERENCE NUMBER: OT217031.
MANUFACTURER REFERENCE NUMBER: OT217031.
ON 5TH JUNE, 2019 MAQUET SAS BECAME AWARE ABOUT AN ISSUE WITH ONE OF THE SURGICAL LIGHT- VOLISTA STANDOP. AS IT WAS STATED, PAINT WAS DAMAGED AND CHIPPED FROM THE FORK OF DEVICE. THERE WAS NO INJURY REPORTED, HOWEVER IT WAS DECIDED TO REPORT THIS ISSUE BASED ON THE POTENTIAL, AS ANY PARTICLES FALLING OFF FROM THE LIGHT INTO STERILE FIELD OR DURING OPERATION MIGHT BE A SOURCE OF CONTAMINATION. MANUFACTURER REFERENCE NUMBER: (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 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).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 484977 | VOLISTA STANDOP | LIGHT, SURGICAL, CEILING MOUNTED | FSY | MAQUET SAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |