Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LAAX INC TIGERPAW SYSTEM II; STAPLE, IMPLANTABLE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 06/25/2014
Event Type  malfunction  
Manufacturer Narrative
The second used device's lot number was 0910m with the expiration date 01aug2016.Health hazard evaluation (hhe) was completed.
 
Event Description
7 out of 9 connectors of the first used tigerpaw system ii device, 5 connectors out of 9 out of 9 of the second tiger paw system ii device and 9 connectors out of 9 of the third tigerpaw system ii device were not engaged.The stapler was used to complete procedure.There was no bleeding based on this event.There were no patient negative effects.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TIGERPAW SYSTEM II
Type of Device
STAPLE, IMPLANTABLE
Manufacturer (Section D)
LAAX INC
livermore CA
Manufacturer Contact
lioudmila modylevskaia
151 lindbergh ave
suite i
livermore, CA 94551
9254494108
MDR Report Key4988451
MDR Text Key23444884
Report Number3008788191-2015-00078
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 06/26/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/05/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/01/2017
Device Model NumberTP15AJ09
Device Lot Number1121M
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer06/30/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/26/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2013
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
-
-