MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. TIP COVER ACCESSORY; ENDOSCOPIC ELECTROSURGICAL

Model Number 400180-14

Device Problem Detachment Of Device Component (1104)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/10/2017

Event Type  malfunction  

Manufacturer Narrative

The mcs tip cover accessory will not be returned to isi for evaluation; therefore the root cause of the customer reported failure mode cannot be determined.A follow up mdr will be submitted if the instrument is returned or if additional information is received.This complaint is being reported due to the following conclusion: it was alleged that the mcs tip cover accessory fell inside the patient.The tip cover accessory was reported to have been retrieved during the same da vinci surgical procedure.Although, there was no report of patient harm, adverse outcome or injury, it is unknown what caused the tip cover accessory to fall inside the patient.

Event Description

It was reported that during a da vinci-assisted right nephrectomy surgical procedure, the tip cover accessory that was installed on a monopolar curved scissors (mcs) instrument fell inside the patient.The tip cover accessory was retrieved during the same procedure with an unspecified instrument.The procedure was completed and no adverse event was reported.On (b)(4) 2017 intuitive surgical inc., (isi) contacted the site's robotics coordinator and obtained the following additional information: the tip cover accessory that was installed on the monopolar curved scissors (mcs) instrument fell inside the patient right under the surgeon's vision.The surgeon immediately retrieved the tip cover accessory.It was also confirmed that the surgeon never took his eye off the tip cover accessory.It was also confirmed that there were no instrument collisions reported.The robotics coordinator also confirmed that the cannula and the instruments were inspected prior to use.The robotics coordinator confirmed that the procedure was completed robotically.The surgical task of cutting tissue was completed with another mcs instrument.The robotics coordinator confirmed that there was no patient harm, adverse outcome or injury.The robotics coordinator also confirmed that the tip cover accessory was contaminated and hence it was discarded.

• Brand Name: TIP COVER ACCESSORY
• Type of Device: ENDOSCOPIC ELECTROSURGICAL
• 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: 6985219
• MDR Text Key: 90763417
• Report Number: 2955842-2017-00717
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112263
• 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: 10/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 400180-14
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1