MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC ACROBAT SUV STABILIZER SYSTEM; STABILIZER, HEART

Model Number	OM-9000Z
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital reported that during surgery using acrobat suv stabilizer system, even when they turned the knob, the arm part was not firmly fixed, so they stopped using it.A different lot of product was prepared and used, and the surgery was completed without incident.There was no impact or damage to the patient.The cardiovascular surgeon who performed the procedure is well-versed in the procedure.There were no procedural delays.
Additional Manufacturer Narrative
(b)(4).The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
(b)(4).Updated field: b4, g3, g6, h2, h3, h6 (type of investigation, investigation findings, component codes, investigation conclusions), h11.Corrected field: d9.The investigation has been started since the complaint was received, the following contents have been conducted: 1.Device historical record review: the records of the reported lot have been reviewed.No non-conformity relevant with the reported issue is observed.All the products had been performed 100% mechanical function test during production.They all passed the function test which demonstrate the knob can be tightened and can also tighten the flexlink arm.2.Trend review: in the 12 months from 28-may 2024 to 27-may 2025 (date of event), the occurrence rate for the reported issue is found to be (b)(4) for acrobat suv/om-9000z, which is under anticipated occurrence rate.3.Device evaluation: device was not received for evaluation, so the specific root cause for the reported issue is impossible to define.4.Reviewing historical investigation records, the failure knob difficult/ unable to tighten-arm does not lock happened before and has been investigated.The most probable root cause for the ¿knob difficult/ unable to tighten-arm does not lock¿ and ¿acme nut lead in thread broken¿ is rotating the knob rapidly during customer using, or rotating the knob leaner or too much strength used, which cause acme screw misaligned with the acme nut lead in thread, acme nut lead in thread broken, the broken lead in thread would potential not smoothly engage or even not engage with the acme screw lead in thread during tightening, then the knob could not be tighten, and link arm could not be tightened.The failure mode is addressed in the risk management file and ifu.The device met all product specifications upon leaving the factory.There were no ncrs identified which could cause or contribute to the reported issue.The complaint history review did not identify an adverse trend.There were no consequences or impacts to the patient.It¿s determined that there is no relation between the batch manufacturing process and the reported failure.The trending will be monitored continuously.

• Brand Name: ACROBAT SUV STABILIZER SYSTEM
• 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: 22212924
• Report Number: 2242352-2025-0000686
• Device Sequence Number: 8158264
• Product Code: MWS
• UDI-Device Identifier: 00607567900004
• UDI-Public: (01)00607567900004(10)3000442677(17)261213
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2025

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: OM-9000Z
• Device Catalogue Number: OM-9000Z
• Device Lot Number: 3000442677
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 06/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2025
• Supplement Date Received by Manufacturer: 10/31/2025
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/13/2024
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN.
• Patient Sex: Unknown