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 Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported to terumo cardiovascular that the lock was broken in half.It is unknown when this event occurred, whether the product was changed out, or if there was any effect on the patient or results of the surgery.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.
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.Component code: 3067- handpiece.Health effect ¿ impact code: 4648- insufficient information.Health effect - clinical code: 4580- insufficient information.Medical device problem code: 1069- break.Investigation findings: 3233 - results pending completion of investigation.Investigation conclusions: 11 - conclusion not yet available.
Additional Manufacturer Narrative
This follow-up report is submitted to fda in accord with applicable regulations.  upon further investigation of the reported event, the following information is new and/or changed: h6 (identification of evaluation codes 10, 3259, 4307).The affected sample was inspected upon receipt to confirm a broken lock plate.Corrosion was observed on the device, including the lock plates.Due to the presence of corrosion, it¿s possible 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
Lock was busted in half.
Event or Problem Description
New information received that indicates, the event occurred during setup, the product was changed out, and the surgery was completed successfully 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 november 06, 2023.The sample was not returned for evaluation; therefore, a thorough investigation could not be performed.Without a returned device a definitive root cause could not be determined.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• 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: 18073553
• Report Number: 1124841-2023-00255
• Device Sequence Number: 7759131
• Product Code: MWS
• UDI-Device Identifier: 00699753450943
• UDI-Public: (01)00699753450943
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/22/2023

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: Other
• Device Expiration Date: 11/12/2024
• Device Model Number: T401162
• Device Catalogue Number: N/A
• Device Lot Number: T00431
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2023
• Supplement Date Received by Manufacturer: 11/09/2023; 12/07/2023
• Initial Report FDA Received Date: 11/06/2023
• Supplement Report FDA Received Date: 12/04/2023; 12/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2020
• 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
• Patient Sex: Unknown