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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 7084
Device Problem Mechanical Problem (1384)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/13/2019
Event Type  malfunction  
Manufacturer Narrative
Per the service engineer at the user facility, the high power printed circuit board (pcb) was defective.
 
Event Description
It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the sternal saw motor did not rotate.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
Updated blocks: h3 and h6.The reported complaint was confirmed.No parts were returned so full evaluation could not be completed.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 Key8611887
MDR Text Key145112606
Report Number1828100-2019-00248
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 company representative,foreig
Type of Report Initial,Followup
Report Date 07/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/15/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number7084
Device Catalogue Number7084
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/28/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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