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

Model Number 15665

Device Problems Component Missing (2306); Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/29/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).End of service life met, no repairs available.Per the user facility, the device will not be returned to the manufacturer.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the cable connector end was missing.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

Serial number should have been blank on the initial emdr submission.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: 7213399
• MDR Text Key: 98311899
• Report Number: 1828100-2018-00032
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 02/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 15665
• Device Catalogue Number: 15665
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1