MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC ACROBAT-I STABILIZER Z; STABILIZER, HEART

Model Number	OM-10000Z
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not yet been returned to maquet cardiac surgery for evaluation.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.Event site name exceeds character limitations: (b)(6).
Event or Problem Description
Associated with tw: (b)(4).The hospital reported that during surgery 2 consecutive stabilizer systems were used where the holding arm could not be locked.
Additional Manufacturer Narrative
(b)(4).Updated sections: b4,b5,d9,g3,g6,h2,h3,h6,h11.The device was returned to the factory for evaluation on 01/28/2026.An investigation was conducted on 01/29/2026.A visual inspection was conducted.Signs of clinical use and evidence of slight blood was observed on the baffle.The device was securely assembled onto a reference retractor blade by sliding the stabilizer base onto the rail and locking the 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 knob of the device was hard to turn, but with force, the knob was able to be turn and tighten the arm.Based on the returned condition of the device as well as the evaluation results, the reported failure "mechanical problem" was confirmed.A manufacturing engineering evaluation was conducted.A mechanical evaluation was performed.The complaint device did show signs of clinical use.Manufacturing engineering investigated the potential mechanical failure by attaching the complaint device on the standard blade to replicate this mechanical failure of flex link arm not being able to tighten upon turning the knob in clockwise direction.Outcome of this test showed no sign of issues with complaint device being able to attach to the standard blade, remaining in locking position, and holding tension in the flex link arm upon turning the knob in clockwise direction.Therefore, mechanical failure of flex link arm not being able to tighten was not confirmed.The lot #3000479002 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.
Event or Problem Description
It was reported that during surgery 2 consecutive stabilizer systems were used where the holding arm could not be locked.Procedure was completed with a new device.There was a delay.No harm to patient.

• Brand Name: ACROBAT-I STABILIZER Z
• 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: 23677727
• Report Number: 2242352-2025-0001243
• Device Sequence Number: 15680992
• Product Code: MWS
• UDI-Device Identifier: 00607567100008
• UDI-Public: (01)00607567100008(10)3000479002(17)270516
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 12/01/2025

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-10000Z
• Device Catalogue Number: OM-10000Z
• Device Lot Number: 3000479002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2025
• Supplement Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN.
• Patient Sex: Unknown