MAUDE Adverse Event Report: TELEFLEX WECKSTAT STAPLE EXTRACTOR 12/BOX; SKIN STAPLER

Catalog Number 525980

Device Problem Torn Material (3024)

Patient Problem No Patient Involvement (2645)

Event Date 02/01/2014

Event Type  malfunction  

Event Description

Alleged issue: it was reported that "the primary packaging shows small tears near the tip of the device while the folding bow dow snot show any defect".No patient injury reported.

Manufacturer Narrative

A device history record (dhr) review did not show issues related to complaint.Device sample received by manufacturer, but investigation is still underway at time of this report.

• Brand Name: WECKSTAT STAPLE EXTRACTOR 12/BOX
• Type of Device: SKIN STAPLER
• Manufacturer (Section D): TELEFLEX; tecate, b.c. ; MX
• Manufacturer Contact: jasmine brown, regulatory affairs ; po box 12600; rtp, NC 27709 ; 9193614124
• MDR Report Key: 3916702
• MDR Text Key: 4513579
• Report Number: 3003898360-2014-00134
• Device Sequence Number: 1
• Product Code: GAG
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 02/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 525980
• Device Lot Number: 01B1300180
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/25/2014
• Date Manufacturer Received: 02/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1