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

Model Number 5590

Device Problems Corroded (1131); Failure To Service (1563)

Patient Problem Not Applicable (3189)

Event Date 02/12/2014

Event Type  malfunction  

Event Description

The service repair technician (srt) reported that during routine testing of the device at the service center, the gear assembly had stiff bearings and visual rust/ corrosion on the sternal saw.There was no patient involvement.

Manufacturer Narrative

This complaint was confirmed by the service repair technician (srt).The srt performed a functional test and observed poor saw operation.Internal inspection revealed the gear assembly to have faulty bearings and signs of corrosion.The srt replaced cam gear assembly, the bearing, along with the o-ring and the rod seal as part of a full preventative maintenance (pm).The unit operated to manufacturer specifications and was returned to clinical use.Per the instructions for use (ifu), the saw hand piece must have a pm every six months for optimum operation.The last pm performed on the sternal saw was in 2010.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

• Brand Name: TERUMO STERNAL SAW II
• Type of Device: STERNAL SAW II
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 6200 jackson rd.; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson rd.; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 3838759
• MDR Text Key: 4616120
• Report Number: 1828100-2014-00219
• 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: Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 02/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 5590
• Device Catalogue Number: 5590
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/27/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/12/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2003
• 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