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

Model Number	OM-9000Z
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital reported that during a coronary artery bypass procedure using acrobat suv stabilizer system.They turned the handle but could not fix it.No problem using spare om-9000z.No health hazard to patient.
Additional Manufacturer Narrative
Trackwise id (b)(4).Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.
Additional Manufacturer Narrative
Trackwise #(b)(4).The investigation has been started since the complaint was received, and the following contents has been conducted: 1.Analysis of production: the dhr of the reported lot 3000230295 has been reviewed.No non-conformity indicating the reported failure 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 flexlink arm can be tightened.2.Trend analysis: in the last 12 months, the occurrence rate is approx.0.028% which is under anticipated occurrence rate.3.Device was not received for evaluation, based on the investigation, there¿s no deficiency identified from production relevant to the ¿knob difficult/ unable to tighten-arm does not lock¿ issue prior to this complaint.It is not indicated that it is the production problem, and also not indicated a manufacturing defect caused or contributed to the reported failure during the investigation.Since the event occurred during the use of the device and the procedural operation is unavailable for review, and the device is not available for evaluation, the specific root cause cannot be determined.
Event or Problem Description
N/a.

• Brand Name: ACROBAT SUV 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: 16823837
• Report Number: 2242352-2023-00329
• Device Sequence Number: 20549945
• Product Code: MWS
• UDI-Device Identifier: 00607567900004
• UDI-Public: 00607567900004
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2023

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: 03/24/2024
• Device Model Number: OM-9000Z
• Device Catalogue Number: OM-9000Z
• Device Lot Number: 3000230295
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2023
• Supplement Date Received by Manufacturer: 09/20/2023
• Initial Report FDA Received Date: 04/27/2023
• Supplement Report FDA Received Date: 09/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/25/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown