MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC CIRCULAR STAPLER; ENDOSCOPIC TISSUE APPROXIMATION DEVICE

Catalog Number ECS33A

Device Problem Failure to Form Staple (2579)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/25/2020

Event Type  malfunction  

Event Description

The eea stapler was placed, and anvil advanced/aligned & secured under direct vision, in position to use/fire stapler.Once surgeon fired stapler, none of the staples engaged to seal the lumen.Staples were free and not closed.Item was returned to purchasing for investigation with ethicon.

• Brand Name: CIRCULAR STAPLER
• Type of Device: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC; 4545 creek rd.; cincinnati OH 45242
• MDR Report Key: 10238968
• MDR Text Key: 197766181
• Report Number: 10238968
• Device Sequence Number: 1
• Product Code: OCW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ECS33A
• Device Lot Number: T94G07
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/26/2020
• Event Location: Hospital
• Date Report to Manufacturer: 07/07/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 31025 DA
• Patient Weight: 95