MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. MONOPOLAR SCISSORS; SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT

Device Problems Break (1069); Entrapment of Device (1212); Activation, Positioning or Separation Problem (2906); Mechanical Jam (2983)

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

Event Date 11/30/2022

Event Type  malfunction  

Event Description

During robot case, monopolar scissors stopped working.When md visualized the scissor tip, he noticed it was broken.First assist was unable to remove instrument from trocar due to the dysfunction.The whole trocar had to be removed from the patient and a new on inserted.The instrument was still unable to be separated from the trocar.Sent to decontamination to be cleaned and then given to surgery director.

• Brand Name: MONOPOLAR SCISSORS
• Type of Device: SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer road; sunnyvale CA 94086
• MDR Report Key: 16875606
• MDR Text Key: 314628641
• Report Number: 16875606
• 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: 04/19/2023,11/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/19/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/05/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22265 DA
• Patient Sex: Male
• Patient Race: White