MAUDE Adverse Event Report: TELEFLEX MEDICAL VISISTAT 35W 6/BOX; STAPLE, REMOVABLE (SKIN)

Model Number IPN028493

Device Problem Failure to Form Staple (2579)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/19/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).The device history review could not be conducted since the lot number provided is not a valid number.The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that staples will not close properly.

• Brand Name: VISISTAT 35W 6/BOX
• Type of Device: STAPLE, REMOVABLE (SKIN)
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville 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: 10490842
• MDR Text Key: 205882648
• Report Number: 3003898360-2020-00716
• Device Sequence Number: 1
• Product Code: GDT
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/19/2020

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 Model Number: IPN028493
• Device Catalogue Number: 528235
• Device Lot Number: 73J1900860
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/19/2020
• Initial Date FDA Received: 09/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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