MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, INC. CONTOUR; CURVED CUTTER STAPLER

Catalog Number CS40G

Device Problem Defective Device (2588)

Patient Problem No Information (3190)

Event Date 09/24/2018

Event Type  malfunction  

Event Description

Md stated the staple line from the contour stapler is not working.Stapler was collected and went to the risk mgmt.

• Brand Name: CONTOUR
• Type of Device: CURVED CUTTER STAPLER
• Manufacturer (Section D): ETHICON ENDO-SURGERY, INC. ; guaynabo PR 00969
• MDR Report Key: 7914649
• MDR Text Key: 122151621
• Report Number: MW5080176
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CS40G
• Device Lot Number: R9478G
• 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: 58 YR
• Patient Weight: 67