MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. HARMONIC ACE CURVED SHEARS; SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

Model Number 480275

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Insufficient Information (4580)

Event Date 02/23/2023

Event Type  Injury  

Event Description

Harmonic ace curved shear (480275) lot l10221129 alerted "secure attachment" on the ethicon monitor.We followed the listed steps and the error repeated.We then opened a new harmonic, it worked momentarily, and the alert repeated.We switched out the harmonic handpiece cord and the alert did repeat 2 more time, but we were able to finish the case.Reference report: mw5115354.

• Brand Name: HARMONIC ACE CURVED SHEARS
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.
• MDR Report Key: 16466874
• MDR Text Key: 310710552
• Report Number: MW5115353
• Device Sequence Number: 1
• Product Code: NAY
• 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: 02/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 480275
• Device Lot Number: L10221129
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 78 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White