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

Model Number 480275

Device Problems Break (1069); Device Displays Incorrect Message (2591)

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

Event Date 12/04/2020

Event Type  malfunction  

Event Description

Harmonic scalpel generator gave warning that too much pressure was placed on working blade and then instrument broke.Noticed missing blade.Blade found and removed without incident.No injury to patient.Device was removed from field and replaced.

• Brand Name: HARMONIC ACE
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1090 kifer road; sunnyvale CA 94086
• MDR Report Key: 10983016
• MDR Text Key: 220722262
• Report Number: 10983016
• 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: 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 480275
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/07/2020
• Event Location: Hospital
• Date Report to Manufacturer: 12/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 14235 DA