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

Model Number	OM-10000
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital reported that during a coronary artery bypass procedure using acrobat-i stabilizer, they heard a strange sound while rotating the knob and installing the equipment.Failure to lock onto retractor arm was not able to tighten in fixed position even rotated the knob to hear the click sound.After that the stabilizer is working not functional, they decided to replace it with a new one immediately.No procedural delay.No harm to patient.
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.
Additional Manufacturer Narrative
Trackwise # (b)(4).The device was returned to the factory for evaluation on 04/27/2023.An investigation was conducted on 05/02/2023.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.There were no visual defects observed.A mechanical evaluation was conducted.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.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 secured in position when the knob was turned clockwise.The knob did not tightened the arm.When the locking lever was locked, the device was able to be locked on the reference retractor.Based on the returned condition of the device, the reported failure "positioning problem" was confirmed.The lot # 3000251037 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
N/a.

• 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: 16788885
• Report Number: 2242352-2023-00301
• Device Sequence Number: 5691624
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2023

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: 08/08/2024
• Device Model Number: OM-10000
• Device Catalogue Number: OM-10000
• Device Lot Number: 3000251037
• 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: 03/27/2023
• Supplement Date Received by Manufacturer: 05/05/2023
• Initial Report FDA Received Date: 04/21/2023
• Supplement Report FDA Received Date: 05/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown