MAUDE Adverse Event Report: TELEFLEX VISISTAT 35W NON-STERILE; STAPLER

Catalog Number 528236

Device Problems Misfire (2532); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/04/2014

Event Type  malfunction  

Event Description

Complaint alleges: it was reported that the stapler jammed when trying to staple the pt.Customer had to organize another skin stapler.No pt injury reported.

Manufacturer Narrative

No sample is available for the manufacturer to evaluate.

• Brand Name: VISISTAT 35W NON-STERILE
• Type of Device: STAPLER
• Manufacturer (Section D): TELEFLEX; tecate ; MX
• Manufacturer Contact: jasmine brown ; 4024 stirrup creek drive; suite #720; durham, NC 27703 ; 9193614124
• MDR Report Key: 3997785
• MDR Text Key: 19588377
• Report Number: 3003898360-2014-00446
• Device Sequence Number: 1
• Product Code: GAG
• Combination Product (y/n): N
• Reporter Country Code: EZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 06/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 528236
• Device Lot Number: 01B1300360
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1