MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; FORCE BIPOLAR

Model Number 470405-06

Device Problem Break (1069)

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

Event Date 05/21/2021

Event Type  malfunction  

Event Description

It was reported that prior to the start of a da vinci-assisted surgical procedure, the instrument tip was broken.The procedure was completed as planned with no report of patient harm, adverse outcome or injury.The force bipolar instrument is a multi-use instrument with bipolar energy capability.This instrument is designed for dissection, grasping, retraction, and bipolar coagulation of tissue.This instrument allows the user to temporarily apply a strong grip mode, depending on surgical needs.Intuitive surgical, inc.(isi) has attempted to follow up to obtain additional information, however, no further details have been received as of date of this report.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the instrument involved with this complaint and completed the device evaluation.Failure analysis investigation confirmed the customer reported complaint.The instrument was found to have a broken grip at the grip base.A piece approximately 0.04" x 0.37" was found to be broken off the distal end.The broken piece was not returned.The following was found during the device evaluation, but is not related to the reportable finding: visual inspection of the conductor wires and insulation found no physical damage.An electrical continuity test was performed and passed.The instrument was not placed on an in-house system due to its damaged condition and inability to fit through the cannula.A review of the site's complaint history does not show any additional reportable complaints related to this product and/or this event.No images or procedure video were provided for review.A review of the device logs for the force bipolar (470405-06 | n10190930 0117) associated with this event has been performed.Per this review of the logs, the force bipolar was last used on (b)(6) 2020 on system (b)(4), with 6 uses remaining.Based on the information provided at this time, this complaint is being reported due to the following conclusion: failure analysis acknowledges that a fragment was missing from a portion of the device that enters the patient.Based on the information provided, there was no report from the customer that a fragment from the instrument fell into the patient during the procedure.While there was no report of harm or injury to the patient and no report of fragments falling into the patient, the reported failure mode could likely cause or contribute to an adverse event if the fragment(s) did fall into the patient.

• Brand Name: ENDOWRIST
• Type of Device: FORCE BIPOLAR
• 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: 13835344
• MDR Text Key: 297248837
• Report Number: 2955842-2022-10696
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874115930
• UDI-Public: (01)00886874115930(10)N10190930
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180351
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470405-06
• Device Catalogue Number: 470405
• Device Lot Number: N10190930 0117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2022
• Initial Date Manufacturer Received: 02/18/2022
• Initial Date FDA Received: 03/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES