MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. ENDOWRIST;DAVINCI SI; SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

Model Number	420049
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2020
Type of Reportable Event	Malfunction
Event or Problem Description
We had an instrument break while inside the patient during a da vinci hernia repair with the doctor.It was the cadiere forceps and they just quit functioning but they were inside the patient when that happened.Note: forcep checked after removal and it was noted to have zero (0) lives.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer road; sunnyvale CA 94086
• MDR Report Key: 10860009
• Report Number: 10860009
• Device Sequence Number: 16761811
• Product Code: NAY
• UDI-Device Identifier: 00886874111338
• UDI-Public: (01)00886874111338(10)N10181010
• 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): 10/30/2020
• Report Date (Section F): 10/30/2020

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: 420049
• Device Lot Number: N10181010
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/18/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 95
• Date Report Sent to FDA: 10/30/2020