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 Problems Power Problem (3010); Noise, Audible (3273)

Patient Problem Insufficient Information (4580)

Event Date 11/03/2022

Event Type  malfunction  

Event Description

It was reported that the sternal saw was making abnormal noise and would function very slowly then shut off.There were no reported adverse consequences to the patient.No other details regarding the nature of this event were provided.

Manufacturer Narrative

The reported complaint was not verifiable.Multiple diligence attempts for part return were unsuccessful therefore no root cause evaluation could be performed.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
• Manufacturer (Section G): SAME
• Manufacturer Contact: douglas patton ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 15870297
• MDR Text Key: 305173275
• Report Number: 1828100-2022-00404
• 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,Followup
• Report Date: 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/04/2022
• Initial Date FDA Received: 11/28/2022
• Supplement Dates Manufacturer Received: 11/30/2022
• Supplement Dates FDA Received: 12/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2007
• 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