MAUDE Adverse Event Report: TELEFLEX MEDICAL VISISTAT 35W; STAPLER

Catalog Number 528235

Device Problems Bent (1059); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/09/2015

Event Type  malfunction  

Event Description

Alleged event: the device misfired and came out bent.The patient's condition was reported as fine.

Manufacturer Narrative

Qn#(b)(4).The device history review for the product visistat 35w 6/box, lot number 73a1500099 investigation did not show issues related to the complaint.The manufacturer will continue to monitor and trend related events.

Manufacturer Narrative

(b)(4).One (1) stapler of catalog number 528235 visistat 35w 6/box was received not used, closed in original packaging, lot # 73a1500099 was confirmed.During visual inspection was observed that components looked well assembled, no stuck staples in tip the cartridge, staples was not observed misaligned.Functional inspection: stapler was removed from the original package, after stapler was activated and one staple was loaded, closed & released.Stapler was activated several time and a total of (b)(4) staples were closed properly (no deformed); no quality issues were found during testing.Sample received did not confirm the defect reported by the customer staple deformed during visual inspection.A functional inspection was performed with staples received, the device worked properly.Therefore, a corrective action is not required at this time.In addition, all products are 100% tested by manufacturing and this defect would have been detected during the functional testing.

Event Description

Alleged event: the device misfired and came out bent.The patient's condition was reported as fine.

• Brand Name: VISISTAT 35W
• Type of Device: STAPLER
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 4935525
• MDR Text Key: 6036548
• Report Number: 3003898360-2015-00526
• Device Sequence Number: 1
• Product Code: GAG
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,company represent
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 528235
• Device Lot Number: 73A1500099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1