MAUDE Adverse Event Report: ETHICON ENDO SURGERY CONTOUR CURVED CUTTER STAPLER; LAPAROSCOPIC STAPLER

Model Number CS40B

Device Problems Device Operates Differently Than Expected (2913); Difficult to Open or Close (2921)

Patient Problem No Information (3190)

Event Date 06/08/2017

Event Type  malfunction  

Event Description

A contour curved cutter stapler (b)(4) lot #p91u61, would not close, a second "like" device was then utilized, and would not seal properly.Two like devices with same lot numbers are reported.

• Brand Name: CONTOUR CURVED CUTTER STAPLER
• Type of Device: LAPAROSCOPIC STAPLER
• Manufacturer (Section D): ETHICON ENDO SURGERY; guaynabo PR 00969
• MDR Report Key: 6696882
• MDR Text Key: 79672539
• Report Number: MW5070881
• 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: Nurse
• Type of Report: Initial
• Report Date: 07/06/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: CS40B
• Device Catalogue Number: CS40B
• Device Lot Number: P91U61
• 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: 91 YR