MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION HERC III 360; UNIVERSAL STABILIZER ARM

Model Number	T401160
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/24/2021
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.
Event or Problem Description
The user facility reported to terumo cardiovascular that the arm links were stuck.It is unknown whether there was a delay in the procedure, and whether the product was changed out.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
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: (identification of evaluation codes 10, 3331, 3259, 4307).Type of investigation #1: 10 - testing of actual/suspected device type of investigation #2: 3331 - analysis of production records investigation findings: 3259 - improper physical structure investigation conclusions: 4307 - cause traced to component failure the affected sample was inspected upon receipt to confirm links were stuck together.Significant wearing of the etching was observed.Mild corrosion was observed in the area of the lock plates.The links on the affected sample were compared to links from other complaint samples and a stock hercules arm.No obvious indication was observed to indicate why the links were stuck together.All available information has been placed on file in quality management for appropriate tracking, trending and follow-up.
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 april 15, 2021.  upon further investigation of the reported event, the following information is new and/or changed: (follow-up due to additional information).A second follow-up will be submitted upon completion of the investigation and/or submission of new information, thus tcvs references conclusions code 11.) all available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
Event or Problem Description
Additional information received indicates that the product was not changed out, it was used as is and there was no delay at beginning or continuing the procedure.

• Brand Name: HERC III 360
• Common Device Name: UNIVERSAL STABILIZER ARM
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 11675156
• Report Number: 1124841-2021-00083
• Device Sequence Number: 3570868
• Product Code: MWS
• UDI-Device Identifier: 00699753450486
• UDI-Public: (01)00699753450486
• Combination Product (Y/N): N
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/08/2021

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: 02/19/2022
• Device Model Number: T401160
• Device Catalogue Number: N/A
• Device Lot Number: T00645
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/24/2021
• Supplement Date Received by Manufacturer: 04/20/2021; 06/04/2021
• Initial Report FDA Received Date: 04/15/2021
• Supplement Report FDA Received Date: 05/12/2021; 06/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1