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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION SARNS STERNAL SAW II; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL-SARNS STERNAL SAW SYSTEMS
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TERUMO CARDIOVASCULAR SYSTEMS CORPORATION SARNS STERNAL SAW II; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL-SARNS STERNAL SAW SYSTEMS Back to Search Results
Model Number 15670
Device Problem Disconnection (1171)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/23/2019
Event Type  malfunction  
Manufacturer Narrative
Per service repair supervisor, the unit is unrepairable since it reached end of service life (eosl) in 2018.Per the user facility's biomedical engineer, they will be replacing the drill motor with a new battery operated device.
 
Event Description
It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the power cable connection to the saw came apart.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
The reported complaint was confirmed via photo sent in by the user facility.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
 
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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 Key8728139
MDR Text Key148991902
Report Number1828100-2019-00332
Device Sequence Number1
Product Code GFA
Combination Product (y/n)N
PMA/PMN Number
K935391
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 08/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number15670
Device Catalogue Number15670
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received08/09/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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