MAUDE Adverse Event Report: Maquet Cardiovascular LLC Acrobat-i Stabilizer; Stabilizer, Heart

Model Number	OM-10000
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
N/a.
Additional Manufacturer Narrative
(b)(4).Updated sections: b4,g3,g6,h2,h3,h6,h11 the device was returned to the factory for evaluation on july 22, 2026, and the investigation was conducted on august 19, 2026.A visual inspection identified signs of clinical use and evidence of blood.No visual defects were observed on the intact returned device.The device was securely assembled onto a reference retractor blade by sliding the stabilizer base onto the rail and engaging the locking lever.The knob was evaluated for its ability to tighten the flexlink arm while the locking lever was in both the locked and unlocked positions.The flexlink arm could not be secured when the knob was turned clockwise.The knob continued to spin without tightening the arm.The device was disassembled to determine the cause of the flexlink arm not tightening.The fins of the acme nut were intact and made adequate contact with the knob.However, the external threads of the acme screw were not engaging with the internal threads of the acme nut.This condition explains why the knob continued to spin without tightening the flexlink arm.Lubricant was observed between the threads and within the acme screw.The presence of lubricant is expected because it is applied during assembly in accordance with work instruction, knob assembly.However, the lubricant exhibited a change in viscosity and had solidified on the surfaces of the acme screw and acme nut.Conclusion: based on the returned condition of the device and the evaluation results, the reported failure, ¿mechanical problem,¿ was confirmed.The most probable root cause was a change in the lubricant¿s viscosity and its solidification on the surfaces of the acme screw and acme nut.This condition prevented proper thread engagement, causing the knob to spin without tightening the flexlink arm.Nc-way-2026-021 was initiated to investigate this most probable root cause.The lot #3000552613 history record review was completed.There were no ncmrs, rework, or deviations documented for the reported lot number.Based on the dhr/lhr review results, it was determined that there is no relation between the batch manufacturing process and the reported failure.

• Brand Name: Acrobat-i Stabilizer
• Common Device Name: Stabilizer, Heart
• Manufacturer (Section D): Maquet Cardiovascular LLC; 45 barbour pond drive; wayne NJ 07470
• Manufacturer (Section G): Maquet Cardiovascular LLC; 45 barbour pond drive; wayne NJ 07470
• Manufacturer Contact: arelean guzman ; 45 barbour pond drive; wayne, NJ 07470
• MDR Report Key: 50138017
• Report Number: 2242352-2026-0000655
• Device Sequence Number: 18813260
• Product Code: MWS
• UDI-Device Identifier: 00607567700581
• UDI-Public: (01)00607567700581(10)3000552613(17)280415
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2026

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: OM-10000
• Device Catalogue Number: OM-10000
• Device Lot Number: 3000552613
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/22/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2026
• Supplement Date Received by Manufacturer: 09/22/2026
• Initial Report FDA Received Date: 08/05/2026
• Supplement Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 189 LB