MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, INC. HARMONIC ACE+7 LAPAROSCOPIC SHEARS; INSTRUMENT, ULTRASONIC SURGICAL

Model Number HARLT 36

Device Problem Loss of Power (1475)

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

Event Date 06/28/2020

Event Type  malfunction  

Event Description

Disposable hand piece for harmonic scapula stopped working.Followed all prompts until it said to replace the hand piece.It was not the equipment, just the disposable hand piece.Once the disposable hand piece was replaced, all was well.Fda safety report id# (b)(4).

• Brand Name: HARMONIC ACE+7 LAPAROSCOPIC SHEARS
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, INC.
• MDR Report Key: 10211571
• MDR Text Key: 197148240
• Report Number: MW5095269
• 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: 06/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HARLT 36
• Device Lot Number: U93E8F
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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