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

Model Number	ARDSAT239020A
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
Event site name: (b)(6).Additional information will be provided following the conclusion of the investigation.
Event or Problem Description
On 31st july, 2024 getinge became aware of an issue with one of equipment - xhso.It was stated the handle fell off from screen holder during operation.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
Previous d1 brand name: eqt; corrected d1 brand name: maquet equipment; previous d4 version of model # ard567712901; corrected d4 version of model # ardsat239020a; previous d4 catalog # ard567712901; corrected d4 catalog # none; previous d4 serial # (b)(6); corrected d4 serial # (b)(6); previous d4 unique identifier (udi) #: n/a; corrected d4 unique identifier (udi) #: (b)(4).Getinge became aware of an issue with one of equipment - xhso.It was stated the handle fell off from screen holder during operation.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.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 received by getinge, the issue occurred during surgery.As stated by the subject matter expert at manufacturing site, the detachment between handle holder and aluminum cylinder, which allows bonding of the handle, is probably due to mechanical shocks, collisions or excessive efforts.To prevent any similar incident, the following have been implemented: during the manufacturing the prats are degreased.The quantity of the instant adhesive gel deposited is checked.The adhesive bonding is checked by manual traction during the manufacturing.The user manual #0421101 xs/xd flat screen monitors holders mentions to check the condition of the sterilizable handle.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: 20037486
• Report Number: 9710055-2024-00480
• Device Sequence Number: 6507987
• Product Code: FXR
• UDI-Device Identifier: 03700712416102
• UDI-Public: (01)03700712416102
• 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): 08/22/2024

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: ARDSAT239020A
• Device Catalogue Number: ARD567712901
• 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: 07/31/2024
• Supplement Date Received by Manufacturer: 09/06/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown