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

Model Number	ARDVST229009A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event site telephone: (b)(6).Based on the information collected, it was established that when the event occurred, the surgical lights did not meet its specification, since loosened or broken suspension screws could be considered as technical deficiencies, and in this way the device contributed to event.It is unknown if claimed devices were or were not being used for patient treatment or diagnosis when the event took place.According to subject matter expert at manufacturer¿s, the most probable root cause of suspension fixing screws loosened or broken would be an incorrect installation/ maintenance.In case of loosening, the probable causes of loosening correspond to an improper initial tightening during the installation or a maintenance not in accordance with the manufacturer's recommendations.In case of rupture, the failure of the screws is related to fatigue stresses due to moderate shear overload.All facies have a fatigue failure zone more or less extensive.Initiated at the bottom of the thread, the repeated low mechanical stresses caused the breakage of a first screw.The rupture of the other screws corresponds to progressive propagation of the shear effect.The yearly preventive maintenance program mentions: to check the suspension fixing screws.It is also indicated to not retighten the screws during maintenance.If screws appear loosened replace them.- to replace the 6 fixing screws every 6 years.In april 2019, getinge transmitted the service bulletin 98 on getinge online reminding to carry out preventive maintenance and wearing parts replacement to ensure the device safety.The service bulletin 98 mentions to replace the suspension fixing screws every 6 years during the preventive maintenance.Getinge shall continue to monitor for any further events of this nature and does not propose any further action at this time.
Event or Problem Description
Getinge became aware of an issue with one of surgical lights - volista standop.As it was stated, upon the device inspection one out of the six fixation screws holding the device main tube were loose.There was no injury reported, however, we decided to report the issue in abundance of caution as loose screws holding the device configuration may lead to the device detachment from the ceiling and serious injury.

• Brand Name: STANDOP VOLISTA®
• 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: 20891946
• Report Number: 9710055-2024-0000622
• Device Sequence Number: 21093143
• Product Code: FSY
• UDI-Device Identifier: 03700712401641
• UDI-Public: (01)03700712401641
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K130513
• 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
• Report Date (Section B): 12/10/2024

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: ARDVST229009A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2024
• Initial Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown