MAUDE Adverse Event Report: MAQUET SAS MAQUET EQUIPMENT; HOLDER, CAMERA, SURGICAL

Model Number	ARDSAT239022A
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	09/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.Event site name: (b)(6).
Event or Problem Description
On (b)(6) 2023 getinge became aware of an issue with one of surgical lights - volista access.It was stated the fixing base for the monitor from the monitor holder 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 or serious injury.
Additional Manufacturer Narrative
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.The correction of b5 describe event and problem, d1 brand name and d2a product code for the fda deems required.This is based on the internal evaluation.Previous b5 describe event and problem: on 6th september, 2023 getinge became aware of an issue with one of surgical lights - volista access.It was stated the fixing base for the monitor from the monitor holder 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 or serious injury.Corrected b5 describe event and problem: on 6th september, 2023 getinge became aware of an issue with one of our equipment - sat 13ms0.It was stated the fixing base for the monitor from the monitor holder 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 or serious injury.Previous d1 brand name: volista access.Corrected d1 brand name: maquet equipment.Previous d2a product code for the fda: fsy.Corrected d2a product code for the fda: fxr.
Event or Problem Description
On 6th september, 2023 getinge became aware of an issue with one of our equipment - sat 13ms0.It was stated the fixing base for the monitor from the monitor holder 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 or serious injury.
Additional Manufacturer Narrative
The correction of h3a device evaluated by manufacturer, h3b device not eval provide code, h3c if other provide code - explain fields deems required.This is based on the internal evaluation.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.Getinge became aware of an issue with one of our equipment - sat 13ms0.It was stated the fixing base for the monitor from the monitor holder 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 or serious injury.Client does not accept a quote for the new part.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.The device was not being used for patient treatment upon the event occurrence.According to the information gathered, the issue was discovered during start-up of the device.Root cause analysis was performed by subject matter expert at manufacturer¿s.The analysis is following: the most probable root cause is that this plate has been intentionally removed by a technician.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: MAQUET EQUIPMENT
• Common Device Name: HOLDER, CAMERA, SURGICAL
• 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: 17771907
• Report Number: 9710055-2023-00710
• Device Sequence Number: 7289003
• Product Code: FXR
• UDI-Device Identifier: 03700712417246
• UDI-Public: (01)03700712417246
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 09/19/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ARDSAT239022A
• Device Catalogue Number: ARD515050999
• 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: 09/06/2023
• Supplement Date Received by Manufacturer: 09/26/2023; 07/31/2024
• Initial Report FDA Received Date: 09/19/2023
• Supplement Report FDA Received Date: 11/06/2023; 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/23/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown