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

Model Number 470296

Device Problems Break (1069); Material Frayed (1262)

Patient Problem Insufficient Information (4580)

Event Date 05/06/2021

Event Type  malfunction  

Event Description

During the robotic surgery, the surgeons noticed that the large suture cut needle driver was broken inside of the patient.The metal strings used to rotate the device became broken and frayed.The device was taken out of the patient and inspected.The surgeons replaced the instrument for a new one and continued the surgery.The broken instrument was taken off the sterile field.Manufacturer response for da vinci xi robotic instrument, intuitive large suture cut needle driver (per site reporter).The intuitive representative has been notified.

• Brand Name: ENDOWRIST
• Type of Device: SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer road; sunnyvale CA 94086
• MDR Report Key: 11811694
• MDR Text Key: 250187081
• Report Number: 11811694
• 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: Nurse
• Type of Report: Initial
• Report Date: 05/10/2021

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: 470296
• Device Catalogue Number: 470296
• Device Lot Number: N102002110120
• 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: 05/10/2021
• Event Location: Hospital
• Date Report to Manufacturer: 05/12/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 20440 DA
• Patient Weight: 63