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

Model Number	OM-10000
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital reported that during a coronary artery bypass procedure, acrobat-i stabilizer rotating knob cannot be fixed.Flexlink arm led to the failure of the position to lock.Thus, they changed to a new one immediately and solved the problem.There is no delay in surgery or damage to the patient.
Additional Manufacturer Narrative
Tw id (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
Trackwise#: (b)(4).The device was returned to the factory for evaluation on 11/30/2023.An investigation was conducted on 12/7/2023.The acrobat-i stabilizer was returned opened and the other accessories were returned sealed in their packaging.A visual inspection was conducted.Signs of clinical use and no evidence of blood were observed on the device.The device was evaluated for its mechanical function.The device was securely assembled onto a reference retractor blade by sliding the stabilizer base onto the rail and locking the lever.An attempt was made to tighten the flexlink arm while the locking lever was in both the locked and unlocked positions by turning the knob clockwise.The flexlink arm could not be adjusted, positioned, and locked into place using the knob while in the locked or unlocked positions.Based on the returned condition of the device and evaluation results, the reported failure "positioning problem" was confirmed.The lot # 3000313502 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
• Manufacturer (Section G): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• Manufacturer Contact: arelean guzman ; 45 barbour pond drive; wayne, NJ
• MDR Report Key: 18291840
• Report Number: 2242352-2023-01018
• Device Sequence Number: 6696091
• Product Code: MWS
• UDI-Device Identifier: 00607567700581
• UDI-Public: 00607567700581
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2024

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 Expiration Date: 05/23/2025
• Device Model Number: OM-10000
• Device Catalogue Number: OM-10000
• Device Lot Number: 3000313502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2023
• Supplement Date Received by Manufacturer: 01/12/2024
• Initial Report FDA Received Date: 12/08/2023
• Supplement Report FDA Received Date: 01/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown