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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JUSTRIGHT SURGICAL JUSTRIGHT 5MM STAPLER
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JUSTRIGHT SURGICAL JUSTRIGHT 5MM STAPLER Back to Search Results
Model Number JR-ST25-2.0-6
Device Problem Firing Problem (4011)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 07/01/2017
Event Type  Injury  
Manufacturer Narrative
The analysis is pending.
 
Event Description
During a left lower lobe lung and pulmonary sequestration, the stapler misfired on the feeding vessel to the sequestration and on the main bronchus.The bronchus and the vessel were sealed by placing clips.
 
Event Description
During a left lower lobe lung and pulmonary sequestration, the stapler misfired on the feeding vessel to the sequestration and on the main bronchus.The bronchus and the vessel were sealed by placing clips.
 
Manufacturer Narrative
Procedure notes from a case that occurred on (b)(6) 2017 were provided by the surgeon.The notes were reviewed by the justright surgical medical advisor on january 7, 2019.He indicated he could not determine what occurred during the procedure without a video.The pictures were not clear enough to show where the misfires occurred or what may have caused or contributed to them.There was no information in the procedure notes that indicated the nature of the misfires.
 
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Brand Name
JUSTRIGHT 5MM STAPLER
Type of Device
JUSTRIGHT 5MM STAPLER
Manufacturer (Section D)
JUSTRIGHT SURGICAL
331 s 104th st
ste 200
louisville CO 80027
MDR Report Key8182096
MDR Text Key131052286
Report Number3010377594-2018-00008
Device Sequence Number1
Product Code GAG
UDI-Device Identifier10865163000109
UDI-Public10865163000109
Combination Product (y/n)N
PMA/PMN Number
K132472
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 12/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberJR-ST25-2.0-6
Device Catalogue NumberJR-ST25-2.0-6
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received12/07/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age21 DA
Patient Weight3
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