MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI; TIP COVER ACCESSORY

Model Number 400180-14

Device Problem Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/30/2022

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) has requested the mcs tip cover accessory involved with this complaint to be returned for failure analysis.However, as of the date of this report, the accessory has not been received.A follow-up mdr will be submitted if the instrument or the accessory are returned (post failure analysis evaluation) or if additional information is received.Verification of the accessory product via system logs cannot be performed because accessory device product details are not captured in the system log.A review of the site's complaint history does not show any additional complaints related to this product.No image or video of the last procedure was provided for review.This complaint is considered a reportable malfunction due to the following conclusion: it was alleged that the mcs tip cover accessory was not properly installed and had an exposed orange line between the edge of the instrument and the mcs tip cover accessory.In the event the mcs tip cover accessory is compromised, it is possible for energy to discharge in an area other than the instrument tip.Per the i&a user manual "it is important to exercise caution when using a energized endowrist monopolar curved scissors instrument to help avoid unintended contact with tissue adjacent to the area to be cauterized." failure to follow these precautions will result in electrical arcs from the wrist and alternate site burns.At this time, the cause of the reported issue has not been determined.

Event Description

It was reported that during a da vinci-assisted bilateral inguinal hernia surgical procedure, the monopolar curved scissors (mcs) tip cover accessory was not going all the way down to the ridge in the instrument and there was a slight orange line observed between the edge of the tip cover accessory and the instrument.The technical support engineer (tse) recommended the customer to not perform the procedure with the mcs tip cover accessory not fully or correctly installed.The procedure was completed as planned with no patient harm.The mcs) tip cover accessory, when used as intended, provides insulation over a section of the endowrist monopolar curved scissors instrument so that radio frequency (rf) energy is only available at the instrument scissor tips.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information on 6th april, 2022: the customer stated that the first mcs) tip cover accessory was removed and replaced prior to using it in the procedure.The customer did not use an installation tool.The mcs instrument was functioning properly during procedure.

• Brand Name: DA VINCI
• Type of Device: TIP COVER ACCESSORY
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 14256749
• MDR Text Key: 299456848
• Report Number: 2955842-2022-11352
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 400180-14
• Device Catalogue Number: 400180
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/30/2022
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES