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

Model Number 410322

Device Problems Retraction Problem (1536); Detachment of Device or Device Component (2907)

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

Event Date 08/21/2019

Event Type  malfunction  

Event Description

During a surgical procedure, the intuitive surgical, davinci si, vessel sealer blade would not retract.This subsequently lead to a system failure fault.Intuitive surgical fenestrated bipolar forceps electrical attachment (internal prongs) separated from the davinci device during the procedure.Fda safety report id(s)# (b)(4).

• Brand Name: ENDOWRIST ONE DAVINCI VESSEL SEALER
• Type of Device: SYSTEM, SURGICAL, COMPUTER, CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC. ; sunnyvale CA 94086
• MDR Report Key: 8930867
• MDR Text Key: 155693116
• Report Number: MW5089294
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/21/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 410322
• Device Catalogue Number: 410322
• Device Lot Number: M10180824
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 60 YR