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

Model Number 15670

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/04/2019

Event Type  malfunction  

Event Description

It was reported that prior to use of the device for a cardiopulmonary bypass (cpb) procedure, the cooling blades of the sternal saw loosened causing an issue with the motor.As a result, an alternative device was employed.The surgical procedure was completed successfully.There was a delay in the surgical procedure of approximately 15 minutes.There was no blood loss, nor adverse consequences to the patient.

Event Description

Per clinical review: the surgical team had a sternal saw that stopped working during set up for a procedure on (b)(6) 2019, while testing the saw prior to using on a patient.According to the information available, the cooling blades loosened causing the clever to break, therefore the saw was deemed unusable for the procedure.The manufacturer's service technician is unaware of what they are considering cooling blades and clever.This non-working sternal saw caused a 15 minute delay in bringing the surgical patient to the operating theater.The sternal saw was exchanged out, and the non-working unit was not used on the patient.There was no harm or blood loss, since the patient was not exposed to the non-working unit.

Manufacturer Narrative

Evaluation is in progress, but not yet concluded.

Manufacturer Narrative

Upated blocks: h3 and h6.H3: there are no parts available to repair this sternal saw so an evaluation was not completed.The reported complaint was not verifiable since there was not an evaluation done.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: SARNS STERNAL SAW II
• 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
• MDR Report Key: 9125015
• MDR Text Key: 160532345
• Report Number: 1828100-2019-00516
• Device Sequence Number: 1
• Product Code: GFA
• Combination Product (y/n): N
• PMA/PMN Number: K935391
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 03/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 15670
• Device Catalogue Number: 15670
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1