MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC ACCESSRAIL PLATFORM (STANDARD BLADE); INSTRUMENTS, SURGICAL, CARDIOVASCULAR

Model Number	SB-1000
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Related to 810583.The hospital reported that the standard blades (left blade) were not staying on the ua-5001 retractor, the tabs did not secure the blades.There was no procedural delay.A replacement device was used to complete the procedure.No injuries reported.
Additional Manufacturer Narrative
Trackwise 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.
Additional Manufacturer Narrative
(b)(4).The device was returned to the factory for evaluation on 04/28/2023.An investigation was conducted on 05/10/2023.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 blades were attached to the retractor with no visual or physical difficulties observed.The blade that was attached to the left side of the retractor would not stay attached.An engineer evaluation was conducted.Please see attached engineer evaluation video.Based on the returned condition of the device as well as the evaluation results, the reported failure "mechanical problem" was confirmed.The lot # 3000293769 history record review was completed.There were ncmrs , rework, or deviations documented for the reported lot number.Based on the dhr/lhr review results, it was determined that there is relation between the batch manufacturing process and the reported failure.The failure mode is being addressed and investigated under maquet's supplier corrective action request (scar) system.The root cause is supplier manufacturing particularly assembly problem.There were no consequences or impact to the patient.
Event or Problem Description
N/a.

• Brand Name: ACCESSRAIL PLATFORM (STANDARD BLADE)
• Common Device Name: INSTRUMENTS, SURGICAL, CARDIOVASCULAR
• 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: 16961682
• Report Number: 2242352-2023-00390
• Device Sequence Number: 5392312
• Product Code: DWS
• UDI-Device Identifier: 00607567700215
• UDI-Public: 00607567700215
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2023

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: 01/29/2025
• Device Model Number: SB-1000
• Device Catalogue Number: SB-1000
• Device Lot Number: 3000293769
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2023
• Supplement Date Received by Manufacturer: 08/17/2023
• Initial Report FDA Received Date: 05/19/2023
• Supplement Report FDA Received Date: 08/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2023
• 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: UNK.; UNKNOWN.
• Patient Sex: Unknown