MAUDE Adverse Event Report: INTUITIVE SURGICAL 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 09/28/2021

Event Type  malfunction  

Event Description

During initial use of harmonic ace curved shears a relax pressure on blade message was noted then the device stopped working. Fda safety report id# (b)(4).

• Brand Name: HARMONIC ACE CURVED SHEARS
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL; sunnyvale CA 94086
• MDR Report Key: 12751629
• MDR Text Key: 280511291
• Report Number: MW5105133
• 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

• Type of Report: Initial
• Report Date: 11/02/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 480275
• Device Catalogue Number: 480275
• Device Lot Number: I90210730
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No