VOLISTA 600 SF
Report
- Report Number
- 9710055-2019-00081
- Event Type
- Malfunction
- Date Received
- March 13, 2019
- Date of Event
- February 18, 2019
- Report Date
- October 1, 2019
- Manufacturer
- MAQUET SAS
- Product Code
- FSY
- PMA / PMN Number
- K130513
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR
- Reporter Occupation
- OTHER
Narratives
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).
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).
MAQUET SAS BECAME AWARE OF AN ISSUE WITH SURGICAL LIGHT VOLISTA DEVICE RELATED TO CRACKED BRACKET. 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 NOT BEING USED FOR THE PATIENT TREATMENT. DURING THE INVESTIGATION IT WAS FOUND THAT THE OCCURRENCE RATE FOR THE ISSUE OF THE LIGHT HEAD SHAFT BREAKING IS LOW (TOTAL OF 15 COMPLAINTS IN THE LAST 5 YEARS OF DAILY USE OF A LARGE NUMBER OF SIMILAR DEVICES). THE INVESTIGATION WAS PERFORMED BY PRODUCT SPECIALISTS AT THE MANUFACTURER. IT WAS ESTABLISHED THAT THE ROOT CAUSE OF THIS INCIDENT IS THAT ONE OF THREE SCREWS AND ITS LOCK WASHER IS MISSING. THE LACK OF MARKS ON METAL AT THE SCREW LOCATION IS CONCRETE EVIDENCE OF THAT FACT. THIS SCREW HAS BEEN FORGOTTEN ON THE ASSEMBLY LINE DURING MANUFACTURING PROCESS. THE CONTROL PROCESS HAS BEEN REINFORCED SINCE JANUARY, 2016 AND THE CHECK OF THE PRESENCE OF THESE 3 SCREWS IS NOW REQUIRED. TO SUM UP, THE ISSUE OCCURRENCE IS DUE TO MANUFACTURING-MAN ERROR. THE AFFECTED DEVICE ARE NOW BEING UPDATED DURING FIELD SAFETY CORRECTIVE ACTION MSA-2018-001-IU. THE DEVICE INVOLVED IN THE EVENT WAS FOUND TO BE IN THE SCOPE OF MENTIONED FSCA AND ACTION WAS PERFORMED ON SEPTEMBER, 2019, THEREFORE GETINGE DOES NOT PROPOSE ANY OTHER ACTION AT THIS TIME.
MANUFACTURER REFERENCE NUMBER #198334.
MANUFACTURER REFERENCE NUMBER # (B)(4).
ON (B)(4) 2019 MAQUET (B)(4) BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS- VOLISTA. AS IT WAS STATED, THE BRACKET INSIDE THE CUPOLA IS BROKEN. THERE IS NO INJURY REPORTED HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS THE BREAKAGE OF THE BRACKET MAY LEAD TO THE DETACHMENT OF THE CUPOLA, AND THEN LEAD TO AN ADVERSE EVENT. (B)(4).
MNAUFACTURER 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.
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).
MANUFACTURER REFERENCE NUMBER # (B)(4).
(B)(4).
MANUFACTURER REFERENCE NUMBER # (B)(4).
MNAUFACTURER REFERENCE NUMBER: (B)(4).
MANUFACTURER REFERENCE NUMBER # (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 210059 | VOLISTA 600 SF | LIGHT, SURGICAL, CEILING MOUNTED | FSY | MAQUET SAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |