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

Model Number	ARDVCS209018A
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	02/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.H3 other text : device not returned to manufacturer.
Event or Problem Description
On 9th february, 2024 getinge became aware of an issue with one of surgical lights - volista access.It was stated the caches have fallen.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 in case of reoccurrence.
Event or Problem Description
Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
The initial reporter was biomedical technician.; the correction of d1 brand name, d4 catalog # and d4 serial #, h3a device evaluated by manufacturer? h3b device not eval provide code, h3c if other provide code -explain, h4 manufacture date fields deems required.This is based on the internal evaluation.Previous d1 brand name: volista access; corrected d1 brand name: volista; previous d4 catalog # ard568805908; corrected d4 catalog # blank; previous d4 serial # (b)(6); corrected d4 serial # (b)(6)/(b)(6) ; previous h3a device evaluated by manufacturer?: no; corrected h3a device evaluated by manufacturer?: yes; previous h3b device not eval provide code: other; corrected h3b device not eval provide code: n/a; previous h3c if other provide code -explain: device not returned to manufacturer; corrected h3c if other provide code -explain: n/a; previous h4 manufacture date: 2022-07-06; corrected h4 manufacture date: (b)(6) 2022; getinge became aware of an issue with one of surgical lights - volista access.It was stated the caches have fallen.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 in case of reoccurrence.Defective part spring arm (b)(4) (ard568921930) was replaced and device was back to usage.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 devices were or were not being used for patient treatment or diagnosis when the event took place.Root cause analysis was performed by subject matter expert at manufacturer¿s.The analysis is following: to date, the exact root cause of the failure observed could not be determined.Corrective action being considered: oasys arm covers fixation to be improved.The following are being considered: changing the current screws m4*6 to m4*8; - stating a tightening torque value for the cover screws and adding installation information about plastic dust covers in the installation manuals.; curative action: manufacturer recommends refitting the covers and gluing the fixing screws with loctite low-strength thread lock 222 in order to solve the issue.Getinge shall continue to monitor for any further events of this nature and does not propose any further action at this time.

• Brand Name: 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: 18693222
• Report Number: 9710055-2024-00142
• Device Sequence Number: 8509342
• Product Code: FSY
• UDI-Device Identifier: 03700712420505
• UDI-Public: (01)03700712420505
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 09/11/2024

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
• Operator of Device: Health Professional
• Device Model Number: ARDVCS209018A
• Device Catalogue Number: ARD568805908
• 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: 02/09/2024
• Supplement Date Received by Manufacturer: 09/06/2024
• Initial Report FDA Received Date: 02/13/2024
• Supplement Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown