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

Model Number 5590

Device Problem Material Twisted/Bent (2981)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The reported issue was discovered during reprocessing of the device.As per the user facility's technician, they were able to repair the device themselves and it is in working order.

Event Description

It was reported that during use of the device for a non-clinical activity, the blade protector of the sternal saw was bent.There was no patient involvement.

Manufacturer Narrative

The reported complaint was not verifiable.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: 8161018
• MDR Text Key: 130492815
• Report Number: 1828100-2018-00636
• 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
• Report Date: 01/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2018
• 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?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1