VOLISTA
Report
- Report Number
- 9710055-2018-00106
- Event Type
- Malfunction
- Date Received
- October 12, 2018
- Date of Event
- September 12, 2018
- Report Date
- March 28, 2019
- Manufacturer
- MAQUET SAS
- Product Code
- FSY
- PMA / PMN Number
- K130513
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
Narratives
THE ISSUE IS BEING INVESTIGATED BY THE 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).
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).
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). HE DATA WAS CORRECTED FROM (B)(6) 2014 TO (B)(6) 2014 DUE TO A TYPO MISTAKE. MAQUET SAS BECAME AWARE OF A CUSTOMER¿S PROBLEM WITH THE VOLISTA DEVICE. AS IT WAS STATED BY THE TECHNICIAN, THERE WERE CRACKS IN THE PAINT OBSERVED, SPECIFICALLY AT THE ARC OF THE FORK. 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. WHEN REVIEWING SIMILAR REPORTABLE EVENTS REGISTERED FOR VOLISTA SURGICAL LIGHT WE WERE ABLE TO FIND SEVERAL SIMILAR ISSUES COMPARED TO THE PROBLEM INVESTIGATED HEREIN. IN NONE OF THE COMPLAINTS A SERIOUS INJURY OR DEATH OCCURRED. BASED ON THE INFORMATION COLLECTED TO DATE IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL LIGHT DID NOT MEET THE MANUFACTURER¿S SPECIFICATION. THE MOST PROBABLE ROOT CAUSE THAT THE CRACKS APPEAR WAS THE DETACHMENT OF THE BONDED PARTS OF FORK. IT WAS ESTABLISHED THAT THE CRACKS WERE LOCATED ONLY ON THE OUTER COATING AND THERE WAS NO IMPACT TO THE INTERNAL STRUCTURE OF THE FORK ASSEMBLY. THE BREAKS ON THE COATING CORRESPOND TO THE EXCESSIVE GAP BETWEEN TWO MECHANICAL PARTS UNDER THE OUTER MATERIAL. WE HAVE NO INFORMATION REGARDING THE EXACT TIME WHEN THE DEFECT FIRST APPEARED OR IF IT WAS BEING USED FOR PATIENT TREATMENT IN THE TIME WHEN THE EVENT OCCURRED. A CORRECTIVE/PREVENTIVE ACTION INVESTIGATION INTO THE ISSUE HAS REVEALED THAT THE ISSUE MAY BE THE RESULT OF SEVERAL FACTORS, SUMMARIZED AS ISSUES WITH THE PREVIOUS UNDERSTANDING OF POST-GLUING ASPECTS. A DESIGN CHANGE IMPROVED THE ASSEMBLING METHODS FROM GLUE-BONDING TO WELDING OF THE PARTS IN PRODUCTION, SINCE BEGINNING OF 2017.
ON (B)(6) 2018 MAQUET SAS BECAME AWARE OF AN INCIDENT WITH ONE OF THE SURGICAL LIGHTS - VOLISTA STANDOP. THE FORK BRACKET OF THIS DEVICE BECAME CRACKED. THERE WAS NO INJURY REPORTED. SINCE IT MAY LEAD TO THE FALL OF PAINT CHIPS, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION, AS ANY PART FALLING MIGHT BE A SOURCE OF CONTAMINATION. MANUFACTURER REFERENCE NUMBER: (B)(4).
MANUFACTURER REFERENCE NUMBER: (B)(4).
MANUFACTURER REFERENCE NUMBER: (B)(6).
THE MOST POSSIBLE ROOT CAUSE HAS BEEN ESTABLISHED HOWEVER, IT NEEDS TO BE CONFIRMED. (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. (B)(4). EXEMPTION # E2018005. (B)(4).
THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURER'S SITE. (B)(4). EXEMPTION # E2018005. (B)(4).
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 |
|---|---|---|---|---|---|---|---|
| 799711 | VOLISTA | LIGHT, SURGICAL, CEILING MOUNTED | FSY | MAQUET SAS | STANDOP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |