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

Model Number 410322

Device Problem Retraction Problem (1536)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/08/2020

Event Type  malfunction  

Event Description

During a si robotic hysterectomy, two intuitive surgical endo wrist one vessel sealer failed to retract the blade after firing the staple.

• Brand Name: ENDOWRIST;DAVINCI SI
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer road; sunnyvale CA 94086
• MDR Report Key: 10307324
• MDR Text Key: 199859392
• Report Number: 10307324
• 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: 07/09/2020,07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 410322
• Device Catalogue Number: 410322
• Device Lot Number: M11190423
• 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: 07/09/2020
• Event Location: Hospital
• Date Report to Manufacturer: 07/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1