MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, INC. ETHICON HARMONIC FOCUS SHEARS; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number HAR9F

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 03/16/2022

Event Type  malfunction  

Event Description

The ethicon harmonic focus shears, could not be set up because they would not tighten.No patient injury occurred.A new device used without issue.Fda safety report id # (b)(4).

• Brand Name: ETHICON HARMONIC FOCUS SHEARS
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, INC.
• MDR Report Key: 13839938
• MDR Text Key: 287668131
• Report Number: MW5108337
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HAR9F
• Device Lot Number: 294A42
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2022
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1