MAUDE Adverse Event Report: TELEFLEX MEDICAL VISITAT 35R 6/BOX; SKIN STAPLER

Catalog Number 528135

Device Problems Sticking (1597); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/01/2015

Event Type  malfunction  

Event Description

It was reported that the client was using the stapler for a little while, but when he went to reload the stapler, the latter got stuck and refused to staple.No patient injury reported.Additional information was requested but no additional information was submitted at the time of this report.

Manufacturer Narrative

(b)(4).Device history record (dhr) investigation did not show issues related to this complaint.No correction actions can be established since it is necessary to receive the physical sample to perform a proper investigation and confirm the defect.At this time, due to the lack of defective product, it is not possible to confirm the complaint and to determine the root cause.The manufacturer will continue to monitor and trend relating complaints.

• Brand Name: VISITAT 35R 6/BOX
• Type of Device: SKIN STAPLER
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; prolongacion mision eusebio; kino # 1316,rancho el descanso; tecate, b.c. 2147 8 MX; MX 21478 MX
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd.; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 4749241
• MDR Text Key: 5825029
• Report Number: 3003898360-2015-00329
• Device Sequence Number: 1
• Product Code: GDT
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 528135
• Device Lot Number: 73G140043
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1