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

Model Number 001-401-161

Device Problem Positioning Problem (3009)

Patient Problem No Information (3190)

Event Date 04/20/2017

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).Results: results pending completion of evaluation.Conclusions: conclusion not yet available-evaluation in progress.

Event Description

The user facility reported to terumo cardiovascular that the item was locked up.It won't turn, the ball part of it was stuck.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 may 15, 2017.Upon further investigation of the reported event, the following information is new and/or changed: (date received by manufacturer); (indication that this is a follow-up report); (follow-up due to additional information); (identification of evaluation codes 3317, 213, 67, 92).The sample was not returned for evaluation; therefore, the event was not confirmed.Based on the complaint description that handle was locked into place, it is likely that the handle of the arm was not able to tighten the arm into place, leaving it loose.It is possible for damage to have been caused to the hercules arm through use or re-processing, causing the handle to not move as freely as desired.It is also possible that the difficulty in turning of the handle is due to insufficient lubrication of the handle threads.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: HERCULES III
• 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: 6566276
• MDR Text Key: 75103394
• Report Number: 1124841-2017-00081
• Device Sequence Number: 0
• Product Code: DWB
• Combination Product (y/n): N
• 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: 06/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 001-401-161
• Device Catalogue Number: N/A
• Device Lot Number: 72357
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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