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

Model Number	OM-10000Z
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital reported that during a coronary artery bypass procedure, the surgeon was about to start the anastomosis.When the acrobat-i stabilizer z rotating know continued to rotate and could not be tightened.The procedure was completed with a new device.There was no delay.There was no patient harm.
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 site address line 2 exceeds character limitations: (b)(6).
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Tw # (b)(4).Updated sections: b4,d9,g3,g6,h2,h3,h6,h11.The device was returned to the factory for evaluation on 02/02/2026.An investigation was conducted on 02/05/2026.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.There were no visual defects obseved on the intact device.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 flexlink arm was able to be secured in position when the knob was turned clockwise.The knob did tightened the arm.Based on the returned condition of the device as well as the evaluation results, the reported failure "mechanical problem" was not confirmed.The lot #3000462912 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: 23280751
• Report Number: 2242352-2025-0001127
• Device Sequence Number: 8809449
• Product Code: MWS
• UDI-Device Identifier: 00607567100008
• UDI-Public: (01)00607567100008(10)3000462912(17)270313
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 10/08/2025

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: 3000462912
• 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: 09/19/2025
• Supplement Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2025
• 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: NO.
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 72 KG