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

Catalog Number	ARDVCS209028A
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
Event or Problem Description
On 3rd may, 2024 getinge became aware of an issue with one of surgical lights - volista access ii.It was stated that keypad fell down during a demonstration due to defective adhesive point.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 in case of reoccurrence.
Additional Manufacturer Narrative
(b)(6).Additional information will be provided following the conclusion of the investigation.
Additional Manufacturer Narrative
The correction of g3 date received by manufacturer deems required.This is based on the internal evaluation.Previous g3 date received by manufacturer: 05/03/2024.Corrected g3 date received by manufacturer: 10/07/2024.According to the reporting timeframe we would like to provide the information about current status of the issue.Please be advised that it is being investigated.Additional information will be provided following the conclusion of the investigation.
Event or Problem Description
Manufacturer's reference number (b)(4).
Event or Problem Description
Getinge became aware of an issue with one of surgical lights - volista access ii.It was stated that keypad fell down during a demonstration due to defective adhesive point.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 in case of reoccurrence.
Additional Manufacturer Narrative
Initial reporter was operating room staff.The correction of b5 describe event and problem deems required.This is based on the internal evaluation.Previous b5 describe event and problem: on 3rd may, 2024 getinge became aware of an issue with one of surgical lights - volista access ii.It was stated that keypad fell down during a demonstration due to defective adhesive point.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 in case of reoccurrence.Corrected b5 describe event and problem: getinge became aware of an issue with one of surgical lights - volista access ii.It was stated that keypad fell down during a demonstration due to defective adhesive point.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 in case of reoccurrence.Defective part was replaced by vcs2-400/600 - light head keypad with tk (ard368877555).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.According to the information gathered, the issue was discovered during demo.Root cause analysis was performed by subject matter expert at manufacturer¿s.The analysis is following: the fact that the keypad detached remains an isolated case for this range of light (vcsii).So far the root cause cannot be established.Nethertheless, the supplier has been informed about this problem.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: 20469714
• Report Number: 9710055-2024-0000569
• Device Sequence Number: 17980155
• Product Code: FSY
• UDI-Device Identifier: 03700712420611
• UDI-Public: (01)03700712420611
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 10/17/2024

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 Catalogue Number: ARDVCS209028A
• 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: 05/03/2024
• Supplement Date Received by Manufacturer: 10/07/2024; 01/28/2025
• Initial Report FDA Received Date: 10/17/2024
• Supplement Report FDA Received Date: 12/31/2024; 01/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown