MAUDE Adverse Event Report: MAQUET SAS VOLISTA STANDOP; LAMP, SURGICAL

Model Number	ARDVST229017A
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	06/22/2023
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 22th june, 2023 getinge became aware of an issue with one of surgical lights - volista standop.It was stated the handle dropped from the device.We decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination or serious injury.
Additional Manufacturer Narrative
Getinge became aware of an issue with one of surgical lights - volista standop.It was stated the handle dropped from the device.We decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination or serious injury.It was established that when the event occurred, the surgical light did not meet its specification due to dropped handle, which could be considered as technical deficiencies and in this way the device contributed to the event.Provided information does not indicate if upon the event occurrence, the device was or was not being used for patient treatment.When reviewing similar reportable events for the same device type, it was confirmed that in the last 5 years, registered for the issue of detached handle volista surgical lights, there is no event which led to the serious injury.Comparing the number of claimed devices to the install base, we conclude that the failure ratio is very low for the issue investigated herein.As stated by the subject matter expert at maquet sas, the most probable root causes of this incidents are: a wrong fitting of the sterilizable handle onto the light head.The user manual ifu 01781 en 19 on pages 56-59 mentions all the recommendations about the sterilizable handle and particularly how to fit it onto the light.Sterlisable handle are consumable and must be replaced if any default is detected prior to use: cracks defective locking mechanism.Standard life expectancy is 50 sterilisation cycles (ifu 01781 en 19, page 92).Maquet sas recommends to inform the customers about the hazards in cases of non-compliance of these instructions.We believe the related devices are performing correctly in the market.We also believe that if the manufacturer recommendation had been followed the incident could 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: LAMP, SURGICAL
• 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: 17191781
• Report Number: 9710055-2023-00467
• Device Sequence Number: 5869514
• Product Code: FTD
• UDI-Device Identifier: 03700712401740
• UDI-Public: (01)03700712401740
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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): 06/23/2023

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: ARDVST229017A
• Device Catalogue Number: ARDVST229017A
• 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: 06/22/2023
• Supplement Date Received by Manufacturer: 01/15/2024
• Initial Report FDA Received Date: 06/23/2023
• Supplement Report FDA Received Date: 01/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/04/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown