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 01/26/2015

Event Type  malfunction  

Manufacturer Narrative

Health hazard evaluation (hhe) was completed.

Event Description

Not all connectors of the tigerpaw system ii device were engaged.The left atrium appendage was over-sewed w/suture.There was 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 ste i; livermore, CA 94551 ; 9254494108
• MDR Report Key: 5045299
• MDR Text Key: 25148326
• Report Number: 3008788191-2015-00120
• 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
• Reporter Occupation: Physician
• Remedial Action: Recall
• Report Date: 01/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TP15AJ07
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2015
• 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
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 128