MAUDE Adverse Event Report: INTUITIVE SURGICAL INC. DA VINCI SI PERMANENT CAUTERY HOOK; SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

Model Number 420183

Device Problems Break (1069); Physical Resistance/Sticking (4012)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/31/2018

Event Type  malfunction  

Event Description

Si robotic permanent cautery hook got stuck in arm 1.Instrument broke in pt, zero fragments reported in pt.Port had to be removed in order to remove instrument from pt.

• Brand Name: DA VINCI SI PERMANENT CAUTERY HOOK
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL INC.; sunnyvale CA 94086
• MDR Report Key: 8074435
• MDR Text Key: 127541047
• Report Number: MW5081293
• 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: 11/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 420183
• Device Lot Number: N10180206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2018
• 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: 38 YR