MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. DA VINCI SURGICAL SYSTEM; ENDOSCOPIC INSTRUMENT CONTROL SYSTEM

Device Problem Device Issue (2379)

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

Event Type  malfunction  

Manufacturer Narrative

The following information regarding the alleged device malfunctions are unknown: the hospital names where each device malfunction occurred, the dates the alleged device malfunctions occurred, and identifying device information (i.E.Part and lot ).This complaint is being reported due to the following conclusion: the clinical article lists a number of alleged device malfunctions reported by urologists.However, specific details regarding each device malfunction are unknown.There is no allegation within the article that any patient injuries occurred in relation to the alleged device malfunctions.

Event Description

On (b)(4) 2017, intuitive surgical, inc.(isi) became aware of the journal of endourology article titled, malfunction of the da vinci robotic system during robot-assisted laparoscopic prostatectomy: an international survey (kaushik, et al., 2010).Within the article, table 4, urologist identified causes of robotic malfunction, list the following malfunctions: arm malfunction, camera malfunction, setup joint malfunction, power error, ocular monitor loss, instrument malfunction, breaking of surgeon's console handpiece, software incompatibility, failure of backup battery, and failure of instrument identification.

• Brand Name: DA VINCI SURGICAL SYSTEM
• Type of Device: ENDOSCOPIC INSTRUMENT CONTROL SYSTEM
• Manufacturer (Section D): INTUITIVE SURGICAL,INC.; sunnyvale CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC.,; 950 kifer rd; sunnyvale CA
• Manufacturer Contact: tabitha reed ; 950 kifer rd; sunnyvale, CA ; 4085232420
• MDR Report Key: 6716350
• MDR Text Key: 80218998
• Report Number: 2955842-2017-00452
• 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: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1