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

Model Number	ARDVST229019A
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	01/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Getinge became aware of an issue with one of surgical lights - volista.It was stated that the headlight seal fell off due to broken light cover.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts or particles falling off into sterile field or during procedure may cause contamination or serious injury.
Additional Manufacturer Narrative
Event site name: (b)(6) event site postal code: (b)(6).Additional information will be provided following the conclusion of the investigation.
Additional Manufacturer Narrative
Getinge became aware of an issue with one of surgical lights - volista.It was stated that the headlight seal fell off due to broken light cover.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts or particles falling off into sterile field or during procedure may cause contamination or serious injury.Based on the information collected, it was established that when the event occurred, the surgical light did not meet its specification and in this way the device contributed to event.It is unknown if claimed device was or was not being used for patient treatment or diagnosis when the event took place.The crack, starting at the edge of the underside fixing point located under the peripheral seal, was caused by a collisions or an inadapted cleaning protocol.The underside fixing point located under the peripheral seal is a retention zone, residues of cleaning agent can lead, by stagnation, to a loss of mechanical properties of plastic parts.During the design and the development, of the volista light head, several cleaning tests were carried out, the conclusion of the report cre 15-030 states that no damage was observed to prevent any incident during the surgical procedure, the volista instruction for use ifu 01781 mentions : to perform daily inspections checking that the underside is not damaged.The risk of collision and explains to pre-position the device to avoid it.How to clean and disinfect the light heads.This document includes some recommended products and some prohibited products.The volista light head must be used according the instructions for use.To prevent any degradation it is recommended to avoid collisions and to wipe the surfaces with a dry cloth to make sure that no liquid residue is left on the device after cleaning.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
Manufacturer's reference number (b)(4).

• 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: 21190017
• Report Number: 9710055-2025-0000019
• Device Sequence Number: 12958435
• Product Code: FSY
• UDI-Device Identifier: 03700712401665
• UDI-Public: (01)03700712401665
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup
• Report Date (Section B): 01/20/2025

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
• 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: 01/02/2025
• Supplement Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 01/20/2025
• Supplement Report FDA Received Date: 01/24/2025
• Date Device Manufactured: 09/06/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown