MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION HERC FLEX UNIVERSAL STABILIZER ARM; STABILIZER, HEART

Model Number	T401163
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Terumo has received the device for evaluation; however, the investigation has yet to be completed.Terumo plans on submitting a follow-up report when the investigation is complete and when more information becomes available.For this reason, terumo references evaluation conclusion code 11.H3: evaluation is in progress, but not yet concluded.
Event or Problem Description
The user facility reported to terumo cardiovascular that after cardiopulmonary bypass, when the arm was loosened after the surgery, the red nylon washer was found to have cracked and a part of the nylon washer fell onto the drape.The fallen part was retrieved and moved for cleaning, but it was discovered that one of the balls from the nylon washer was missing.The patient underwent a ct scan; however, the results are unknown.Procedure was completed successfully.
Additional Manufacturer Narrative
This follow-up report is submitted to fda in accord with applicable regulations ¿ and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on november 26,2025.Upon further investigation of the reported event, the following information is new and/or changed: g3 (date received by manufacturer).G6 (indication that this is a follow-up report).H2 (follow-up due to additional information and device evaluation).H3 (device evaluated by manufacturer).H6 (identification of evaluation codes 10, 3331, 4248, 19).The affected sample was inspected upon receipt and confirmed that the red nylon washer was broken.There was also some corrosion noted on the device.However, the device was noted to expire on 2023-08-21; therefore, being used approximately 2 years and 3 months past expiration.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: HERC FLEX UNIVERSAL STABILIZER ARM
• Common Device Name: STABILIZER, HEART
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• Manufacturer (Section G): SAME
• Manufacturer Contact: douglas patton ; 125 blue ball road; elkton, MD 21921 ; 7346634145
• MDR Report Key: 23657841
• Report Number: 1124841-2025-00100
• Device Sequence Number: 10124026
• Product Code: MWS
• UDI-Device Identifier: 00699753450950
• UDI-Public: (01)00699753450950(17)230821(10)T00009
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/21/2023
• Device Model Number: T401163
• Device Catalogue Number: N/A
• Device Lot Number: T00009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2025
• Supplement Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 01/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown