MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION HERC FLEX 360 DEVICE ASSY; UNIVERSAL STABILIZER ARM

Model Number	T401162
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Terumo has not received the device for evaluation; therefore, 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.
Event or Problem Description
The user facility reported to terumo cardiovascular a beating heart with broken thin metal parts.It is unknown when this event occurred, whether the surgery was completed successfully, and if there was a blood loss.Due to the unknown information for this event, it is being reported.Terumo continues to attempt to gain more information regarding this event from the user facility.*there was no delay in the procedure, the product was changed out, with no patient effect.
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 february 13, 2024.Upon further investigation of the reported event, the following information is new and/or changed: b5 (updated describe event or problem); d4 (additional device information - added exp date); g3 (date received by manufacturer) ; g6 (indication that this is a follow-up report) ; h2 (follow-up due to additional information); h3 (updated device evaluated by manufacturer) ; h4 (device manufacture date); h6 (identification of evaluation codes 2645, 3331, 4114, 3259, 19).The affected sample was not returned for evaluation.However, a photo was provided that showed the lock plates broken and corrosion around where the lock plates should be.Due to the presence of corrosion, it was determined that improper reprocessing of the device caused the failure.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
Event or Problem Description
New information received that the event occurred during other - non clinical activity; therefore, there was no patient involvement.

• Brand Name: HERC FLEX 360 DEVICE ASSY
• Common Device Name: UNIVERSAL STABILIZER ARM
• 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: 18694774
• Report Number: 1124841-2024-00026
• Device Sequence Number: 8508873
• Product Code: MWS
• UDI-Device Identifier: 00699753450943
• UDI-Public: (01)00699753450943
• Combination Product (Y/N): N
• Initial Reporter Country: GG
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2024

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: Other
• Device Expiration Date: 12/17/2024
• Device Model Number: T401162
• Device Catalogue Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2024
• Supplement Date Received by Manufacturer: 03/07/2024
• Initial Report FDA Received Date: 02/13/2024
• Supplement Report FDA Received Date: 03/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Patient Sex: Unknown