MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC NONE; TIP COVER ACCESSORY

Model Number 400180

Device Problems Use of Device Problem (1670); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/12/2019

Event Type  Injury  

Manufacturer Narrative

The mcs tip cover accessory has not been returned for evaluation.Therefore, the root cause of the customer reported failure mode cannot be determined.A follow-up mdr will be submitted if the mcs instrument or mcs tip cover accessory is returned (post failure analysis evaluation) or if additional information is received.It is confirmed the site used electro lube.Electro lube is not provided by isi and is not suggested in the mcs tip cover accessory or monopolar curved scissors instructions for use (ifu).The use of electro lube with the mcs instrument has not been validated by intuitive.Therefore, the use of the electro lube is considered to be mishandling/misuse.Moreover: isi¿s ifu also states: caution: failure to adhere to approved operating practices may result in damage to the instruments (surgical and endoscope).Examples of improper practices include: dropping of equipment, collisions, and improper cleaning and sterilization techniques.A damaged instrument may result in fragments falling into the patient.The surgeon confirmed that there was instrument collision during the procedure, which is considered misuse/mishandling.This complaint is being reported due to the following conclusion: it was reported that during a da vinci-assisted surgical procedure, the mcs tip cover accessory fell inside the patient and was found to be missing.As a result, the patient had a subsequent procedure the following day to retrieve the mcs tip cover accessory.Due to misuse mishandling secondary to usage of electro lube and collision of instruments, there is no indication that a malfunction of the mcs instrument or mcs tip cover accessory occurred.

Event Description

It was reported that during a da vinci-assisted myomectomy surgical procedure, during the removal of the monopolar curved scissors (mcs) instrument, the surgical staff noticed that the mcs tip cover accessory was missing.As a result, the patient had a subsequent procedure the following day to retrieve the mcs tip cover accessory.On (b)(6) 2020, intuitive surgical, inc.(isi) received fda voluntary report # mw5091913 for the same reported incident with no additional information.Isi contacted the clinical sales representative (csr) and obtained the following information regarding the reported event: it was reported that the mcs instrument was in use for approximately three hours.At the time of removal of the mcs instrument, the surgical staff noticed that the mcs tip cover accessory was missing.The surgeon recalled seeing the exposed orange shaft of the mcs instrument during the last twenty minutes of fibroid manipulation prior to the fibroid being detached from the uterus.The surgeon confirmed there were internal collisions between the mcs instrument and the laparoscopic tenaculum instrument.The instrument was not removed until the end of the procedure when it was being exchanged for the needle driver instrument.During the removal of the mcs instrument, it is unknown if the wrist was straightened and if there was any resistance felt.The surgeon believes that the potential cause for the mcs tip cover accessory falling inside the patient was either due to incorrect installation or due to usage of electro lube to help the mcs tip cover accessory slide onto the mcs instrument shaft.There were x-rays taken, and the surgeon spent five hours looking for the missing mcs tip cover accessory; however, the mcs tip cover accessory was not found.The csr indicated that on post-operative day#1, the site located the missing mcs tip cover accessory behind the liver via a ct-scan.The patient underwent a traditional laparoscopic surgery that same day to retrieve the mcs tip cover accessory.It was reported that the patient was recovering well.The mcs tip cover accessory will not be returned to isi.There is no video recording of the procedure available for review.

• Brand Name: NONE
• Type of Device: TIP COVER ACCESSORY
• 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: 9572627
• MDR Text Key: 181576792
• Report Number: 2955842-2020-10017
• 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: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 400180
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/12/2019
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention