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 07/25/2014

Event Type  malfunction  

Manufacturer Narrative

Health hazard evaluation (hhe) was completed.

Event Description

The tigerpaw system ii two devices were malfunctioned.An atriclip device was used to complete procedure.There was no bleeding based on this event.There were no patient negative effects.

• 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 Key: 4988449
• MDR Text Key: 23541053
• Report Number: 3008788191-2015-00086
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 07/31/2014

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: 05/01/2017
• Device Model Number: TP15AJ07
• Device Lot Number: 1137M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/31/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• 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
• Patient Age: 61 YR