MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC ENDOSCOPIC CURVED INTRALUMINAL STAPLER; EEA STAPLERS

Catalog Number LAWSON #146618

Device Problem Failure to Form Staple (2579)

Patient Problem No Information (3190)

Event Date 12/01/2017

Event Type  Injury  

Event Description

Two ethicon eea staplers failed.Apparently, the first one was unable to release and the second one was unable to staple.Due to 2 separate issues with the equipment the surgeon chose not to try a 3rd stapler instead he hand sewed the anastomosis and created a diverting ileostomy to prevent dehiscence and leakage complications.Dates of use: (b)(6) 2017.Diagnosis or reason for use: used during ostomy reversal surgery, being used for the reversal of an ostomy.

• Brand Name: ENDOSCOPIC CURVED INTRALUMINAL STAPLER
• Type of Device: EEA STAPLERS
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC; guaynabo PR 00969
• MDR Report Key: 7101066
• MDR Text Key: 94406284
• Report Number: MW5073853
• 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: 12/06/2017
• 2 Devices were Involved in the Event: 1 2

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 Expiration Date: 04/30/2020
• Device Catalogue Number: LAWSON #146618
• Device Lot Number: L4F01A
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/07/2017
• 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 Outcome(s): Hospitalization
• Patient Age: 57 YR
• Patient Weight: 71