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

Model Number 201363

Device Problem Power Problem (3010)

Patient Problem No Patient Involvement (2645)

Event Date 04/13/2019

Event Type  malfunction  

Manufacturer Narrative

A service engineer at the medical facility checked the unit and found that the high power printed circuit board (pcb) was defective.

Event Description

It was reported that during use of the device for a non-clinical activity, the sternal saw did not rotate.There was no patient involvement.

Manufacturer Narrative

Please disregard the previous submission.This reported complaint is a duplicate complaint that is already being investigated.All investigation results will be reported on medwatch #1828100-2019-00248.

• 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: 8592184
• MDR Text Key: 144461615
• Report Number: 1828100-2019-00220
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 05/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201363
• Device Catalogue Number: 201363
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1