MAUDE Adverse Event Report: TELEFLEX MEDICAL VISISTAT 35W NON-STERILE

Catalog Number 528236

Device Problems Difficult to Open or Close (2921); Mechanical Jam (2983)

Patient Problem No Patient Involvement (2645)

Event Date 10/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The facility has communicated that the device is not available for evaluation.P/n 528236 is not being manufactured currently, however, another part number from the same family was used for the verification of failure mode reported in the current manufacturing process and was conducted as follows:13 staplers were taken from the current production from p/n 528235 visistat 35w non-sterile lot# 73j1800742 the staplers were functionally inspected and the issue reported "stapler jamming" was not observed in the current manufacturing process, the staples were loaded and released correctly.The device history review for the product visistat 35r 6/box lot 73a1800774 investigation did not show issues related to the complaint.Corrective actions cannot be established, the customer complaint cannot be confirmed, and the root cause cannot be determined since it is necessary to receive the physical sample to perform a proper investigation and to confirm the alleged defect.If the alleged defective samples become available at a later date, this complaint will be updated accordingly.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that the stapler is not working; sometimes it gets stuck and other times it does not close properly.

• Brand Name: VISISTAT 35W NON-STERILE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 7996791
• MDR Text Key: 124968464
• Report Number: 3003898360-2018-00858
• Device Sequence Number: 1
• Product Code: GAG
• Combination Product (y/n): N
• Reporter Country Code: EZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 528236
• Device Lot Number: 73B1800441
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/09/2018
• Initial Date FDA Received: 10/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1