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

Model Number	ARDVST229008A
Medical Device Problem Codes	Corroded (1131); Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 29th april, 2024 getinge became aware of an issue with one of surgical lights - volista standop.As it was stated, the oxidation occurred on the bushing and started to spread externally.The designated complaint unit employee confirmed based on photographic evidence the rust occurred on the arms and paint was chipping from the arms.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 in case of reoccurrence.
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.
Additional Manufacturer Narrative
The correction ofd1 brand name, d2a product code., d4 version of model #, 4 unique identifier (udi), d4 catalog # deems required.This is based on the internal evaluation.Previous d1 brand name: volista standop corrected d1 brand name: standop volista® previous d2a product code.Ftd corrected d2a product code.Fsy previous d4 version of model # ard568831911 corrected d4 version of model # ardlca219003a previous d4 serial # (b)(6) corrected d4 serial # (b)(6) previous d4 catalog # ard568831911 corrected d4 catalog # none previous d4 unique identifier (udi) #: n/a corrected d4 unique identifier (udi) #: (b)(4) getinge became aware of an issue with one of surgical lights - volista standop.As it was stated, the oxidation occurred on the bushing and started to spread externally.The designated complaint unit employee confirmed based on photographic evidence the rust occurred on the arms and paint was chipping from the arms.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 in case of reoccurrence.Based on the information collected, it was established that when the event occurred, the surgical lights did not meet its specification, since rust occurrence and/or paint chipping 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 as stated by the subject matter expert, peeling paint and/or rust formation were probably caused by: a stagnation of aggressive disinfectant and detergent products due to an inappropriate cleaning protocol.The presence of liquid water or an exposure to humid air due to a high relative humidity of the operating room.The instruction for use indicates the environmental condition for use, the relative humidity must be between 20% and 75%.To prevent any incident the instruction for use mentions to perform daily and monthly inspection in order to detect painting defects, impact marks or other damages.The instruction for use mentions not to clean the device under running water nor spray a solution directly onto the device.Certain cleaning products or procedures may damage the paintwork of the device, which may result in particles falling onto the surgical site during an operation.Fumigation methods are unsuitable for disinfecting the unit and must not be used.The instruction for use mentions to wipe with a dry cloth and to make sure no liquid residue is left on the device after cleaning.To reduce the appearance of rust or the degradation of the surface, the technical manual or maintenance manual mentions in the preventive maintenance protocol to lubricate some parts of device.The instruction for use mentions not to use a damaged device because it may lead to a risk of injury for users or a risk of infection for patients.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: 19266292
• Report Number: 9710055-2024-00315
• Device Sequence Number: 7062212
• Product Code: FSY
• UDI-Device Identifier: 03700712401689
• UDI-Public: (01)03700712401689
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 05/07/2024

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: ARDVST229008A
• Device Catalogue Number: ARD568831911
• 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: 04/29/2024
• Supplement Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 05/08/2024
• Supplement Report FDA Received Date: 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown