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

Model Number 001-401-160

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Type  malfunction  

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 Description

The user facility reported to terumo cardiovascular that the arm stabilizer is broken.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.

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 8, 2017.The sample was not returned for evaluation, and no details of the event were provided; therefore, a complete investigation was not able to be conducted and the complaint was not confirmed as a definitive root cause was not able to be determined.No details of the event were provided; therefore, the actual failure mode of the device is unknown, and possible root causes are not able to be considered.As the hercules arm is a reusable device, and it was reported that the arm broke, it is possible that the arm was damaged during re-use or re-processing.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: HERC III 360
• Type of Device: UNIVERSAL STABILIZER ARM
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 125 blue ball road; elkton MD 21921
• Manufacturer Contact: cathleen hargreaves ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 6312770
• MDR Text Key: 66866471
• Report Number: 1124841-2017-00021
• Device Sequence Number: 0
• Product Code: DWB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 001-401-160
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1