MAUDE Adverse Event Report: JOHNSON & JOHNSON / ETHICON ENDO-SURGERY, INC. ETHICON ENDOPATH ETS-FLEX 45; STAPLE, IMPLANTABLE

Model Number ETS45 RELOAD

Device Problem Defective Component (2292)

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

Event Date 09/02/2019

Event Type  malfunction  

Event Description

A pt was undergoing laparoscopic appendectomy when the stapler malfunctioned requiring it to be removed and replaced with another one.Fda safety report id# (b)(4).

• Brand Name: ETHICON ENDOPATH ETS-FLEX 45
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): JOHNSON & JOHNSON / ETHICON ENDO-SURGERY, INC.
• MDR Report Key: 8992182
• MDR Text Key: 158638435
• Report Number: MW5089702
• 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: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ETS45 RELOAD
• Device Lot Number: T93Z5N
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/10/2019
• 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: 18 YR
• Patient Weight: 106