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

Model Number 480275

Device Problem Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/22/2019

Event Type  malfunction  

Event Description

Shears would not open/work.This occurred with no patient harm.Manufacturer response for harmonic ace curved shears, harmonic ace curved shears da vinci (per site reporter): investigation to be conducted on device failure.

• Brand Name: HARMONIC ACE
• Type of Device: SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer rd; sunnyvale CA 94086
• MDR Report Key: 8662320
• MDR Text Key: 146807335
• Report Number: 8662320
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 00886874112731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/28/2019
• Event Location: Hospital
• Date Report to Manufacturer: 06/03/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1