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

Model Number 400180

Device Problem Detachment Of Device Component (1104)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/16/2018

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc. (isi) has not received the tip cover accessory for failure analysis. Therefore, the root cause of the customer reported failure mode cannot be determined. If additional information is received, a follow-up mdr will be submitted. This complaint is being reported due to the following conclusion: during a da vinci-assisted surgical procedure, it was alleged that the tip cover accessory fell inside the patient. The tip cover accessory was retrieved. However, at this time, 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 surgical procedure, the monopolar curved scissors (mcs) tip cover accessory fell inside the patient. The tip cover accessory got stuck in the trocar. The customer stated that the trocar was discarded and there was no video of the procedure available. The procedure was completed with no report of patient harm, adverse outcome or injury. Intuitive surgical, inc. (isi) followed up and obtained the following additional information from the clinical sales representative (csr): the mcs tip cover accessory appeared to be installed correctly. No part of the orange surface was visible after the mcs tip cover accessory was installed. The mcs tip cover accessory was not installed beyond the orange surface or over the shaft. The mcs instrument is not available for return.

• Brand Name: ENDOSCOPIC ELECTROSURGICAL INSTRUMENT
• Type of Device: TIP COVER ACCESSORY
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale
• Manufacturer Contact: tabitha reed ; 950 kifer rd.; sunnyvale ; 4085232100
• MDR Report Key: 7507635
• MDR Text Key: 108374471
• Report Number: 2955842-2018-10202
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K112263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/17/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 400180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/17/2018
• 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: Reuse