MAUDE Adverse Event Report: TELEFLEX VISISTAT 35R 6/BOX; STAPLER

Catalog Number 528135

Device Problems Separation Failure (2547); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/01/2014

Event Type  malfunction  

Event Description

Complaint alleges: it was reported that the stapler gets blocked.No pt injury reported.

Manufacturer Narrative

The device history report review for the product visistat 35r 6/box, lot #01m1300167 was manufactured on 12/11/2013 a total of (b)(4) pieces.Lot was released on 12/19/2013.Dhr investigation did not show issues related to complaint.The device sample was not received by the mfr at the time of this report.

• Brand Name: VISISTAT 35R 6/BOX
• Type of Device: STAPLER
• Manufacturer (Section D): TELEFLEX; tecate ; MX
• Manufacturer Contact: effie jefferson, rn, regulatory ; po box 12600; durham, NC 27709 ; 9194332672
• MDR Report Key: 4163230
• MDR Text Key: 21238285
• Report Number: 3003898360-2014-00464
• Device Sequence Number: 1
• Product Code: GAG
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 06/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 528135
• Device Lot Number: 01M1300167
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2013
• Type of Device Usage: Unknown
• Patient Sequence Number: 1