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

Model Number	ARDVCS209007A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.
Event or Problem Description
On 23rd april, 2024 getinge became aware of an issue with one of surgical lights - volista access 600.During maintenance it was found that dust cover (part catalog number: hm56053311) from spring arm was missing.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination.
Additional Manufacturer Narrative
The initial reporter was getinge technician.This is based on the internal evaluation.Previous d4 version or model #: ard568805906.Corrected d4 version or model #: ardvcs209007a.Previous d4 catalog #: ard568805906.Corrected d4 catalog #: blank previous d4 serial #: (b)(6).Corrected d4 serial #: (b)(6), previous d4 unique identifier (udi) #: n/a.Corrected d4 unique identifier (udi) #: (b)(4).Previous h4 manufacture date: 2020-02-04.Corrected h4 manufacture date: 2020-02-06 getinge became aware of an issue with one of surgical lights - volista access 600.During maintenance it was found that dust cover (part catalog number: hm56053311) from spring arm was missing.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts 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 spring arm metal cover detachment could be considered as technical deficiencies, and in this way the device contributed to event.Claimed device was 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 causes are: - non-conformity of the metal covers assembly.- degradation of the metal covers.- improper use (collision with another device).Maquet sas analysis shows that the metal strip comes out of the covers when it is not clipped properly.In the scope of our continuous improvement policy, maquet sas initiated a modification file (e131106) to include this dust cover fitting procedure in the technical documentations with all spring arms.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: VOLISTA ACCESS
• 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: 19190023
• Report Number: 9710055-2024-00299
• Device Sequence Number: 15358615
• Product Code: FSY
• UDI-Device Identifier: 03700712401351
• UDI-Public: (01)03700712401351
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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): 04/26/2024

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: ARDVCS209007A
• Device Catalogue Number: ARD568805906
• 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: 04/23/2024
• Supplement Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 04/26/2024
• Supplement Report FDA Received Date: 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown