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

Model Number	ARDEQT239015A
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Getinge became aware of an issue with one of our surgical equipment - eqtxs3216.It was stated the paint was bubbling/chipping on the spring arm.We decided to report the issue in abundance of caution as any paint particles falling off into sterile field or during procedure may cause contamination.
Additional Manufacturer Narrative
Event site name: (b)(6).Additional information will be provided following the conclusion of the investigation.
Event or Problem Description
Manufacturer's reference number (b)(4).
Additional Manufacturer Narrative
Getinge became aware of an issue with one of our surgical equipment - eqtxs3216.It was stated the paint was bubbling/chipping on the spring arm.We decided to report the issue in abundance of caution as any paint particles 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 light did not meet its specification and in this way the device contributed to event.The claimed device was not being used for patient treatment or diagnosis when the event took place.According to the information gathered, the issue was discovered during maintenance.A root cause analysis was conducted by the subject matter expert.As stated: according to information gathered, the cleaning process has not been followed.The customer utilizes a hydrogen peroxide cleaner, heavily saturate the light, and let sit for 10 minutes before drying.Paint peeling and corrosion are probably caused by a stagnation of aggressive disinfectant and detergent products due to an inappropriate cleaning or disinfection protocol.The manufacturer recommends following the instruction for use, where the recommended and prohibited products are mentioned.Alcohol and chloride ions have clearly been identified as prohibited solutions.The damaged parts must be replaced as soon as possible.Getinge shall continue to monitor for any further events of this nature and does not propose any further action at this time.

• 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: 21273092
• Report Number: 9710055-2025-0000037
• Device Sequence Number: 11773591
• Product Code: FXR
• UDI-Device Identifier: 03700712414306
• UDI-Public: (01)03700712414306
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2025

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: ARDEQT239015A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2025
• Supplement Date Received by Manufacturer: 02/11/2025
• Initial Report FDA Received Date: 01/30/2025
• Supplement Report FDA Received Date: 02/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown