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

Catalog Number 528235

Device Problem Output Problem (3005)

Patient Problem No Information (3190)

Event Date 05/28/2019

Event Type  malfunction  

Event Description

Visistat 35w stapler would not work.Fda safety report id# (b)(4).

• Brand Name: VISISTAT 35W
• Type of Device: DISPOSABLE SKIN STAPLER
• Manufacturer (Section D): TELEFLEX MEDICAL
• MDR Report Key: 8683079
• MDR Text Key: 147594487
• Report Number: MW5087205
• Device Sequence Number: 1
• Product Code: GAG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/25/2019
• Device Catalogue Number: 528235
• Device Lot Number: 73A1900829
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Weight: 52