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U.S. Department of Health and Human Services

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

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TERUMO CARDIOVASCULAR SYSTEMS CORP. HERC III 360 UNIVERSAL STABILIZER ARM Back to Search Results
Model Number 001-401-160
Device Problem Unstable (1667)
Patient Problem No Information (3190)
Event Date 02/01/2017
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).
 
Event Description
The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during setup, the arm is not stable. End of the arm to which the stabilizer is fixed is not stable and no longer holds the stabilizer. It is unknown if there was a delay in the procedure, if there was blood loss and 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
The returned sample was visually inspected, during which it was discovered that the expiration date had passed prior to the event date of this complaint. Upon evaluation of the sample, it was confirmed that the collet of the arm would not tighten around a ball attachment of an atlas or titan as it should when the cable wasn't tightened. Once the cable was tightened, as it would be during use, the attachment was completely stable within the arm. As the hercules arm is a reusable device, and the arm allows disposable attachments and stabilizers to be installed and removed to the collet, it is likely that damage occurred to the collet, pushing the prongs out and over time, moving the prongs outward so that they no longer had a tight fit around the ball attachments. All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
 
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Brand NameHERC III 360
Type of DeviceUNIVERSAL 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 Key6397039
MDR Text Key69755941
Report Number1124841-2017-00038
Device Sequence Number0
Product Code DWB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/21/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/10/2017
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number001-401-160
Device Catalogue NumberN/A
Device Lot Number70680
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/28/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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