MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERNAL SAW II BLADE; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL-SARNS STERNAL SAW SYSTEMS

Model Number 5590

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/29/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation is in progress, but not yet concluded.

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the device had a bent blade.As a result, an alternate device was employed.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

The reported complaint was confirmed.The service repair technician duplicated the reported complaint and noted that the protector needs to be replaced.The sternal saw will not be repaired due to it has reached the end of service life.The unit does not meet the manufacturer's specifications.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: STERNAL SAW II BLADE
• Type of Device: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL-SARNS STERNAL SAW SYSTEMS
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 6200 jackson road; ann arbor MI 48103
• Manufacturer Contact: eileen dorsey ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 7128559
• MDR Text Key: 95751362
• Report Number: 1828100-2017-00578
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 03/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5590
• Device Catalogue Number: 5590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/08/2018
• Was Device Evaluated by Manufacturer?: No
• 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