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

Catalog Number 528235

Device Problem Sticking (1597)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/06/2015

Event Type  malfunction  

Event Description

Complaint alleges: during a medical procedure the surgeon found metal clips stuck in the stapler.The medical procedure is unk.However; the pt was fine and no medical intervention was necessary.No pt injury reported.

Manufacturer Narrative

(b)(4).Device sample received by manufacturer, but investigation is still underway at time of this report.

Manufacturer Narrative

(b)(4).One (1) stapler of catalog number 528235 visistat 35w (b)(4) was received used, opened without original packaging; lot # was not confirmed with sample, stapler was received with remaining staples.Functional inspection: stapler was fired for full activation cycle according to indicating the ifu product "the trigger must be squeezed all the way in" and no staple was released.Staples were newly loaded, which formed & released properly.Root cause for this issue; stuck in stapler is due to one staple formed inside the components.From the sample received the defect was observed "stuck in stapler" during functional inspection; the root cause is unknown due to the stapler received was pre-activated.The stapler was activated in different forms and no quality issues were found.However production personnel will notified about the issue.In addition, all products are 100% tested by manufacturing and this defect would have been detected during the functional testing.Conclusion - no conclusion code available that could accurately describe that the complaint was confirmed, but the root cause is unknown.

Event Description

Complaint alleges: during a medical procedure, the surgeon found metal clips stuck in the stapler.The medical procedure is unknown.However; the patient was fine and no medical intervention was necessary.No patient injury reported.

• 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 2147 8; MX 21478
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 4820861
• MDR Text Key: 18291283
• Report Number: 3003898360-2015-00377
• Device Sequence Number: 1
• Product Code: GAG
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 02/19/2019
• Device Catalogue Number: 528235
• Device Lot Number: 01B1400217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/29/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/12/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1