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

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

Health hazard evaluation (hhe) was completed.

Event Description

7 out of 9 connectors of the 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.

• 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: 4988453
• MDR Text Key: 23443827
• Report Number: 3008788191-2015-00080
• 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
• Report Date: 06/30/2014

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: No Information
• Device Expiration Date: 04/01/2017
• Device Model Number: TP15AJ09
• Device Lot Number: 1121M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2014
• 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