MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. NONE; SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

Model Number	430035
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Tip broke while using in patient.Able to locate and retrieve both pieces.

• Brand Name: NONE
• Common Device Name: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer road; sunnyvale CA 94086
• MDR Report Key: 20179766
• Report Number: 20179766
• Device Sequence Number: 8298406
• Product Code: NAY
• UDI-Device Identifier: 00886874114377
• UDI-Public: (01)00886874114377(17)251031(10)K10231026
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/05/2024
• Report Date (Section F): 08/05/2024

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
• Operator of Device: Health Professional
• Device Model Number: 430035
• Device Lot Number: K10231026
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/10/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/10/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 88 KG
• Date Report Sent to FDA: 08/05/2024