MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC ACROBAT-I STABILIZER; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	OM-10000Z
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2025
Type of Reportable Event	Malfunction
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 or Problem Description
The hospital reported that while prepping back table for surgery, they opened acrobat-i vacuum stabilizer system and the stabilizer and part of the tubing were missing from the package.The packaging was sterile and there was no stabilizer or tubing in there.
Additional Manufacturer Narrative
Trackwise id # (b)(4).Updated sections: b4,b5, d9, g-3, g-6, h-2, h3, h-6, h-11.Corrected sections: e3-occupation; h6- health effect ¿ clinical code h6- health effect ¿ impact code.The investigation has been started since the complaint was received, and the following contents have been conducted: 1.Dhr review: the dhr of the reported lot has been reviewed.No non-conformity relevant with the reported issue is observed.All the products had been performed 100% visual inspection and function test during production.They all passed the inspection and function test which demonstrate the part assembly is integrated.2.Trend review: in the last 12 months, this is the only complaint received, the occurrence rate is found to be (b)(4) which is under anticipated occurrence rate.3.The device was not received which could not be evaluated, the reported failure could not be confirmed.The manufacture processes were reviewed and no deficiency indicating the reported failure was observed, which demonstrated the production process are normal and all devices were packaged correctly.Since no picture or using details is available for review, the specific root cause is impossible to define.The ifu has the warnings and precautions that ¿do not use if the product sterilization barrier or its packaging is compromised.¿ and the device missing could be identified by customer before using, there was no patient involved, no ncmrs, rework, or deviations documented for the reported batch.Based on above review results, it was determined that there is no relation between the batch manufacturing process and the reported failure.
Event or Problem Description
The hospital reported that while prepping back table for surgery, they opened acrobat-i vacuum stabilizer system and the stabilizer and part of the tubing were missing from the package.The packaging was sterile and there was no stabilizer or tubing in there.No patient involvement.

• Brand Name: ACROBAT-I STABILIZER
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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: 21579872
• Report Number: 2242352-2025-0000254
• Device Sequence Number: 8868371
• Product Code: GEI
• UDI-Device Identifier: 00607567100008
• UDI-Public: (01)00607567100008(10)3000441687(17)261210
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2025

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: 3000441687
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2025
• Supplement Date Received by Manufacturer: 05/29/2025
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 06/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/10/2024
• 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: UNKNOWN.
• Patient Sex: Unknown