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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LAAX INC. TIGERPAW SYSTEM II; STAPLE, IMPLANTABLE

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LAAX INC. TIGERPAW SYSTEM II; STAPLE, IMPLANTABLE Back to Search Results
Model Number TP15AJ09
Device Problem Use of Device Problem (1670)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/26/2014
Event Type  malfunction  
Manufacturer Narrative
Health hazard evaluation (hhe) was completed.
 
Event Description
4 out of 9 connectors of the tigerpaw system ii device were not engaged.The second tigerpaw system ii device was successfully used to complete procedure.There was no bleeding based on this event.There were no patient negative effects.
 
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Brand Name
TIGERPAW SYSTEM II
Type of Device
STAPLE, IMPLANTABLE
Manufacturer (Section D)
LAAX INC.
livermore CA
Manufacturer Contact
lioudmila modylveskaia
151 lindbergh ave
suite i
livermore, CA 94551
9254494108
MDR Report Key4988454
MDR Text Key23445764
Report Number3008788191-2015-00079
Device Sequence Number1
Product Code GDW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K111064
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Physician
Remedial Action Recall
Report Date 06/27/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/01/2016
Device Model NumberTP15AJ09
Device Lot Number0898M
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer07/10/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/05/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-1461-2015, Z-1462-2015
Patient Sequence Number1
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