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

Model Number	T401161
Medical Device Problem Codes	Positioning Problem (3009); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/22/2021
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.
Event or Problem Description
The user facility reported to terumo cardiovascular that the knob will no longer tighten and the arm does not hold a position.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
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: 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).H4 (device manufacture date).H6 (identification of evaluation codes 3331, 4114, 3221, 4315).Type of investigation #1: 3331 - analysis of production records.Type of investigation #2: 4114 - device not returned.Investigation findings: 3221 - no findings available.Investigation conclusions: 4315 - cause not established.The affected sample was not returned; therefore, a thorough investigation could not be conducted.It is not possible to determine a true root cause to this event.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: b5: (updated describe event or problem).G3: (date received by manufacturer).G6: (indication that this is a follow-up report).H2: (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 that indicates that the product was changed out.The unit was taken out of service when it would not hold position, and another unit was put in its place.

• Brand Name: HERCULES III
• Common Device Name: UNIVERSAL STABILIZER ARM
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 11675067
• Report Number: 1124841-2021-00082
• Device Sequence Number: 16906519
• Product Code: MWS
• UDI-Device Identifier: 00699753450493
• UDI-Public: (01)00699753450493
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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,distri
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/10/2021

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: 06/06/2022
• Device Model Number: T401161
• Device Catalogue Number: N/A
• Device Lot Number: T00777
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/22/2021
• Supplement Date Received by Manufacturer: 04/27/2021; 06/07/2021
• Initial Report FDA Received Date: 04/15/2021
• Supplement Report FDA Received Date: 05/20/2021; 06/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1