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

Model Number TP15AJ07

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/17/2014

Event Type  malfunction  

Manufacturer Narrative

Health hazard evaluation (hhe) was completed.

Event Description

Two (2) out of seven (7) connectors of the tigerpaw system ii were not engaged.The second tigerpaw system ii device was used to complete procedure mitral valve repair/ablation.There were no known patient negative effects.

• Brand Name: TIGERPAW SYSTEM II
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): LAAX INC; livermore CA
• Manufacturer Contact: loudmila modylevskaia ; 151 lindbergh ave ste i; livermore, CA 94551-0000 ; 9254494108
• MDR Report Key: 4992159
• MDR Text Key: 23540769
• Report Number: 3008788191-2015-00103
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K111064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Remedial Action: Recall
• Report Date: 10/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2017
• Device Model Number: TP15AJ07
• Device Lot Number: 1049M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1461-2015, Z-1462-2015
• Patient Sequence Number: 1