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

Model Number	T401161
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/12/2020
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.(b)(4).
Event or Problem Description
The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during setup, the arms of the nylon washers were broken.Per user facility, they executed exactly the instructions given on the ifu as regards cleaning, sterilization and lubrication.The surgical procedure was postponed due to unavailability of the device.No known impact or consequence to patient.The product was not changed out.
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 june 8, 2020.Upon further investigation of the reported event, the following information is new and/or changed: h6 (identification of evaluation codes 10, 3331, 3252, 4315), method code #1: 10 - testing of actual/suspected device, method code #2: 3331 - analysis of production records, results code: 3252 - fracture problem, conclusions code: 4315 - cause not established.The affected sample was returned, however, the broken washer was not returned, so a thorough investigation could not be conducted.A picture provided with the complaint show that the washer is discolored and broken.This kind of discoloration is observed when improper reprocessing techniques are utilized.Additionally, the product has been expired for more than 12 months.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• 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: 10130097
• Report Number: 1124841-2020-00129
• Device Sequence Number: 13982326
• Product Code: MWS
• UDI-Device Identifier: 00699753450493
• UDI-Public: (01)00699753450493
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2020

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: 05/13/2019
• Device Model Number: T401161
• Device Catalogue Number: N/A
• Device Lot Number: T00160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/18/2020
• Supplement Date Received by Manufacturer: 07/31/2020
• Initial Report FDA Received Date: 06/08/2020
• Supplement Report FDA Received Date: 08/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1