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

Model Number 15675

Device Problem Failure to Power Up (1476)

Patient Problem No Patient Involvement (2645)

Event Date 11/04/2014

Event Type  malfunction  

Event Description

It was reported that during the use of the device for a non-clinical activity, the variable speed footswitch for the sternal saw was not turning on.There was no pt involvement.

Manufacturer Narrative

Eval is in progress, but not yet concluded.This complaint is related to mdr #1828100-2014-01010.The customer was checking the unit before sending it back to the end user.The unit was steam sterilized in (b)(4) 2014.

• 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: 4297456
• MDR Text Key: 20783540
• Report Number: 1828100-2014-01009
• 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: User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 11/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 15675
• Device Catalogue Number: 15675
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/11/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/04/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2009
• 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