MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; FORCE BIPOLAR

Model Number 470405-06

Device Problem Electrical Shorting (2926)

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

Event Date 06/26/2019

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the instrument involved with this complaint and completed the device evaluation.Failure analysis was able to confirm the reported complaint.The instrument failed electrical continuity test.There was no obvious damage to the conductor wire.Confirmed that electrical continuity failed for one wire to grip combination.Housing was removed and both conductor wires were still connected to energy id board pins.Instrument was disassembled to find one wire broken near the main tube of the chassis interface.It is possible that wire was improperly routed during assembly, causing damage and eventual breakage of wire as instrument was used.Based on the information provided, this event is being reported due to the following conclusion: it was reported that during a da vinci-assisted surgical procedure, the force bipolar instrument had cautery issues.The conductor wire was damage with no evidence or claim of user mishandling or misuse found during failure analysis suggests that if the malfunction were to recur, it could cause or contribute to an adverse event.

Event Description

It was reported that during a da vinci-assisted surgical procedure, the force bipolar instrument had cautery issues.There was no report of patient harm, adverse outcome or injury.

• Brand Name: ENDOWRIST
• Type of Device: FORCE BIPOLAR
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: david wang ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 8903679
• MDR Text Key: 209671554
• Report Number: 2955842-2019-10637
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180351
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470405-06
• Device Lot Number: N10190129 0005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2019
• Date Manufacturer Received: 07/30/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1