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

Model Number	OM-9000Z
Medical Device Problem Codes	Positioning Problem (3009); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital reported that during an endoscopic vein harvesting procedure, acrobat suv vacuum stabilizer system, st the fixing part of the acrobatic suv om-9000z was loose and could not be fixed properly.A new device was used to complete the procedure with no delays.There were no effects to patient.
Additional Manufacturer Narrative
Tw id (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
(b)(4).Corrected sections: h6--medical device ¿ problem code corrected from "3190" to "3009".
Event or Problem Description
The hospital reported that during an endoscopic vein harvesting procedure, acrobat suv vacuum stabilizer system, st the fixing part of the acrobatic suv om-9000z was loose and could not be fixed properly.The knob was turned to secure (close) the product, but it was not secured properly.A new device was used to complete the procedure with no delays.There were no effects to patient.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Trackwise #(b)(4).The device was returned to the factory for evaluation on 03/04/2024.A visual inspection was conducted.Signs of clinical use and evidence of blood were observed on the device.There were no visual defects observed on the device.A mechanical evaluation was conducted.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 can tighten 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 as well as the evaluation results, the reported failure "fixing part could not be fixed properly" was not confirmed.A lot history record review was completed for the lot 3000349055, the last lot shipped to the account prior to the event/aware date.There were no ncrs, rework, or deviations documented for the last lot shipped to the account.Based on the dhr/lhr review results, there's no deficiency identified from production relevant to the reported acrobat suv failure prior to this complaint.All the products had been performed and 100% passed visual inspection and mechanical test during production, which demonstrates the knob can be tighten and also can tighten the link arm.

• 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: 18480259
• Report Number: 2242352-2024-00035
• Device Sequence Number: 12461047
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/27/2024

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 Model Number: OM-9000Z
• Device Catalogue Number: OM-9000Z
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2023
• Supplement Date Received by Manufacturer: 01/15/2024; 05/09/2024
• Initial Report FDA Received Date: 01/09/2024
• Supplement Report FDA Received Date: 02/07/2024; 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown