MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC ETHICON HARMONIC ELECTROCAUTERY; INSTRUMENT, ULTRASONIC SURGICAL

Model Number W7031D

Device Problem Failure to Cut (2587)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/13/2023

Event Type  malfunction  

Event Description

The device stopped burning and cutting the tissue, leading us to open another device.

• Brand Name: ETHICON HARMONIC ELECTROCAUTERY
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• MDR Report Key: 17224764
• MDR Text Key: 318099845
• Report Number: 17224764
• Device Sequence Number: 1
• Product Code: LFL
• 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: 06/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: W7031D
• Device Lot Number: W7031D
• 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: 06/13/2023
• Event Location: Hospital
• Date Report to Manufacturer: 06/29/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1