MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO STERNAL SAW II

Model Number 15665

Device Problems Failure To Service (1563); Device Operates Differently Than Expected (2913)

Patient Problem Not Applicable (3189)

Event Date 01/23/2014

Event Type  malfunction  

Manufacturer Narrative

Technical support advised the biomed to use lubricant on the units.The saw cables are being returned to the mfr for preventative maintenance (pm).Lubricant can not be shipped at this time.The unit was tested and issue confirmed when received at the mfr.The service repair technician (srt) observed erratic cable operation during a functional test.Per the instructions for use (ifu), the saw cabling must have a pm every six months for optimum operation.The saw cable inner core was cleaned and lubricated with full pm as well.The product will be sent to service to br brought to the mfrs specifications before being returned to the customer.If additional info becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

Event Description

The user facility's biomedical engineer (biomed) reported that during routine testing of the device at the service ctr, that the sternal saw cable was noisy.The biomed determined it was noisy when testing the saw.There was no pt involvement.

• Brand Name: TERUMO STERNAL SAW II
• Type of Device: STERNAL SAW II
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson rd.; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 3826422
• MDR Text Key: 16587891
• Report Number: 1828100-2014-00178
• Device Sequence Number: 1
• Product Code: GFA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K935391
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 15665
• Device Catalogue Number: 15665
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/07/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1