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

Catalog Number 528235

Device Problems Activation, Positioning or Separation Problem (2906); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/05/2015

Event Type  malfunction  

Event Description

Complaint alleges: the hosp reported that the staples were stuck on the stapler during use.A new skin stapler had to be used.It was reported that there were no clinical consequences to the pt, and that he is fine.

Manufacturer Narrative

Qn# (b)(4).Device history record (dhr) investigation did not show issues related to this complaint.No corrective 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 mfr will continue to monitor and trend relating complaints.

• 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 bc 2147 8; MX 21478
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 4563523
• MDR Text Key: 5460262
• Report Number: 3003898360-2015-00159
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 07/30/2019
• Device Catalogue Number: 528235
• Device Lot Number: 73G1400442
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1