MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, INC. ECHELON; STAPLE, IMPLANTABLE

Model Number PLEE60A

Device Problem Torn Material (3024)

Patient Problem No Patient Involvement (2645)

Event Date 11/07/2016

Event Type  malfunction  

Event Description

Prior to the stapler being fired, surgeon noted that the laparoscopic stapler had a small tear/slit in the flexible rubber section part that articulates.Stapler removed from field.Device was being ready to be fired by surgeon, but surgeon noted the tear prior to firing, the device did not reach the patient.

• Brand Name: ECHELON
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, INC.; 4545 creek road; cincinnati OH 45242
• MDR Report Key: 6088787
• MDR Text Key: 59468652
• Report Number: 6088787
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/31/2019
• Device Model Number: PLEE60A
• Device Catalogue Number: PLEE60A
• Device Lot Number: #N92C7G
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/07/2016
• Event Location: Hospital
• Date Report to Manufacturer: 11/07/2016
• Type of Device Usage: N
• Patient Sequence Number: 1