MAUDE Adverse Event Report: MAQUET SAS VOLISTA STANDOP; LIGHT, SURGICAL, CEILING MOUNTED

Model Number	ARDVST229019A
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.Device not returned to manufacturer.
Event or Problem Description
On 19th july, 2022 getinge became aware of an issue with one of our surgical light ¿ volista standop 600.It was claimed with the issue of paint peeling from fork, what was confirmed by the photographic evidence.There was no injury reported, however, we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.
Additional Manufacturer Narrative
The correction of h4 manufacture date deems required.This is based on the internal evaluation.Previous h4 manufacture date: 2016-08-24.Corrected h4 manufacture date: 2016-09-07.Getinge became aware of an issue with one of our surgical light ¿ volista standop 600.It was claimed with the issue of paint peeling from fork, what was confirmed by the photographic evidence.There was no injury reported, however, we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.Based on the information collected, it was established that when the event occurred, the surgical lights did not meet its specification, since appearance of paint peeling could be considered as technical deficiency, and in this way devices contributed to event.It remains unknown whether the affected device was or was not being used for patient treatment or diagnosis when the event occurred.When reviewing reportable events for this type of issues we were able to establish that the received incidents with paint peeling are occurring at low ratio.As stated by subject matter expert at the manufacturing site, the paint chip or paint damages are due to: impacts, collisions (abnormal use).The operating manual (ifu 01781 en 16, pages 38-39) includes the instructions to pre-position the arms prior to use, in order to prevent damages.To prevent any similar incident, it is recommended to avoid the collisions between devices.Visual inspections during the cleaning allow to detect the painting defect, we recommend to perform corrective maintenance to rectify the default after its detection.Minor paint chip can be repaired with touch up paint, nevertheless, the parts impacted by serious damage must be replaced.All maquet sas products comply with: ¿ iec 60601-1 ed.2.0 & ed.3.0 general requirements for basic safety and essential performance.¿ iec 60601-2-41 particular requirements for the safety of surgical luminaires and luminaire for diagnosis.¿ paint definition pfc066.This procedure defines maquet sas¿s requirements for all painted parts.¿ disinfection products test: the aim of these tests is to detect any incompatibility with disinfectant.We believe the related devices are performing correctly in the market.We also believe that if the manufacturer¿s recommendation had been followed the incident would have been avoided.Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.
Event or Problem Description
Manufacturer's reference number (b)(4).

• Brand Name: VOLISTA STANDOP
• Common Device Name: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• Manufacturer (Section G): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• Manufacturer Contact: pascal jay ; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 15216026
• Report Number: 9710055-2022-00338
• Device Sequence Number: 14732759
• Product Code: FSY
• UDI-Device Identifier: 03700712401665
• UDI-Public: 3700712401665
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ARDVST229019A
• Device Catalogue Number: ARDVST229019A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2022
• Supplement Date Received by Manufacturer: 08/19/2022
• Initial Report FDA Received Date: 08/12/2022
• Supplement Report FDA Received Date: 09/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/07/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown