MAUDE Adverse Event Report: TELEFLEX MEDICAL VISISTAT 35W 6/BOX; SKIN STAPLER

Catalog Number 528235

Device Problem Sticking (1597)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/06/2015

Event Type  malfunction  

Event Description

Complaint alleges: during a medical procedure the surgeon found metal clips stuck in the stapler.The medical procedure is unknown.However, the patient was fine and no medical intervention was necessary.No patient injury reported.

Manufacturer Narrative

Qn#(b)(4).Device sample received by manufacturer, but investigation is still underway at time of this report.

Manufacturer Narrative

(b)(4).Device history record (dhr) investigation did not show issues related to this complaint.One (1) stapler from catalog number 528235 visistat 35w 6/box was received used, opened without original package, lot # was not confirmed, and stapler was received with remaining staples.During visual inspection it was observed that the components looked well assembled, however, trigger component was pre-activated, one stuck staple in the tip of the cartridge, and staple formed inside the components.Functional inspection: stapler was fired for full activation cycle according to the ifu product "the trigger must be squeezed all the way in." the staples were loaded, closed & released properly.Although; from the sample received it was observed the defect reported by the customer stuck in stapler during visual inspection, the root cause for this issue is considered unknown due to the stapler received was pre-activated.Stapler was activated in different forms, and no quality issues were found.No actions will be taken at this time.However; production personnel will notified about the issue.

Event Description

Complaint alleges: during a medical procedure, the surgeon found metal clips stuck in the stapler.The medical procedure is unknown.However; the patient was fine and no medical intervention was necessary.No patient injury reported.

• Brand Name: VISISTAT 35W 6/BOX
• Type of Device: SKIN STAPLER
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 2147 8; MX 21478
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 4820839
• MDR Text Key: 5841491
• Report Number: 3003898360-2015-00373
• Device Sequence Number: 1
• Product Code: GAG
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 01/15/2019
• Device Catalogue Number: 528235
• Device Lot Number: 01A1400152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/24/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/08/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1