FDA Adverse Event Malfunction Summary report: N

VOLISTA STANDOP

MDR report key: 8434071 · Received March 19, 2019

Report

Report Number: 9710055-2019-00098
Event Type: Malfunction
Date Received: March 19, 2019
Date of Event: February 26, 2019
Report Date: April 9, 2020
Manufacturer: MAQUET SAS
Product Code: FSY
PMA / PMN Number: K130513
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: BR
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

GETINGE BECAME AWARE OF AN ISSUE WITH A SURGICAL LIGHT VOLISTA DEVICE. AS IT WAS STATED, RUST OCCURRED ON THE DIFFERENT PARTS OF VOLISTA DEVICE. 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 MAY NOT HAVE MET 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. RUSTED SURFACE IS INDICATED BY OUR PRODUCT EXPERTS TO LIKELY BE CAUSED BY AN INFLUENCE OF CHEMICAL DETERGENTS USED FOR CLEANING, OR, POTENTIALLY AN ISSUE IN THE PAINT PREPARATION PROCESS WITH A PREVIOUS SUPPLIER. DUE TO THE LIMITED INFORMATION RECEIVED FROM THE CUSTOMER, DESPITE OUR BEST EFFORTS, WE WERE NOT ABLE TO IDENTIFY THE DEVICE AND THEREFORE COULD NOT CHECK THE SUPPLIER FOR THIS PAINTED SUB-ASSEMBLY. WE BELIEVE THAT IF THE MAINTENANCE AND CARE INSTRUCTIONS AT THE CUSTOMER WOULD HAVE BEEN FOLLOWED THE INCIDENT LIKELY 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.

Additional Manufacturer Narrative · 0

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: (B)(4).

Description of Event or Problem · 0

MANUFACTURER'S REFERENCE NUMBER: (B)(4).

Description of Event or Problem · 0

ON (B)(4) 2019 MAQUET (B)(4) BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS- VOLISTA. AS IT WAS STATED, THE RUST OCCURRED ON THE DEVICE. THERE WAS NO INJURY REPORTED HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY RUST PARTICLE FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MIGHT BE A SOURCE OF CONTAMINATION. (B)(4).

Additional Manufacturer Narrative · 1

THE ISSUE IS BEING INVESTIGATED BY MANUFACTURING SITE.

Additional Manufacturer Narrative · 1

THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.

Additional Manufacturer Narrative · 1

THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE. (B)(4). EXEMPTION # E2018005. (B)(4).

Additional Manufacturer Narrative · 1

THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.

Additional Manufacturer Narrative · 1

THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.

Additional Manufacturer Narrative · 1

THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.

Additional Manufacturer Narrative · 1

THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.

Additional Manufacturer Narrative · 1

THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE. THE PART REPORTED IN THIS REPORT IS A PART OF THE SURGICAL LIGHT CONFIGURATION # (B)(4). EXEMPTION # E2018005. (B)(4).

Additional Manufacturer Narrative · 1

THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE. (B)(4). EXEMPTION # E2018005. (B)(4).

Additional Manufacturer Narrative · 1

THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.

Additional Manufacturer Narrative · 1

THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.