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

Model Number 400180-14

Device Problem Detachment Of Device Component (1104)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/29/2018

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc. (isi) received the tip cover accessory involved with this complaint and completed the investigation. Failure analysis was unable to confirm the customer reported failure. The reported symptom was not found related to the reported accessory. Visual inspection of the tip cover did not find any pieces missing from the distal or proximal ends. The tip cover was installed on an in house instrument and installed on a system. The instrument was installed and removed through a cannula without an issue; tip cover did not slide off. The monopolar curved scissors (mcs) instrument related to this event has not been returned for evaluation. A follow-up mdr will be submitted if additional information is received. This complaint is being reported due to the following conclusion: during a da vinci-assisted surgical procedure, the mcs tip cover accessory allegedly detached and fell inside the patient. The tip cover accessory was retrieved. Although, no patient harm was reported at this time it is unknown what caused the tip cover accessory to fall off inside the patient.

Event Description

It was reported that during a da vinci-assisted surgical procedure, the monopolar curved scissors (mcs) tip cover accessory "detached" from the mcs instrument during removal from the cannula and fell inside the patient. The tip cover was retrieved laparoscopically. The mcs instrument with the tip cover accessory installed was in use for less than 20 minutes. The tip cover was inspected prior to use and did not make any contact with other instruments or hard material during the surgical procedure. The planned surgical procedure was completed and no patient harm, adverse outcome or injury was reported.

• 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: 7645885
• MDR Text Key: 112861159
• Report Number: 2955842-2018-10331
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: KR
• PMA/PMN Number: K112263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other

Reporter Occupation

• Type of Report: Initial
• Report Date: 06/04/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 400180-14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2018

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse