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

Model Number 471205-17

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907); Difficult to Open or Close (2921)

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

Event Date 04/03/2024

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted nephroureterectomy surgical procedure, the fenestrated bipolar forceps (fbf) instrument stopped moving, and instrument jaws failed to open while it was grasping the patient¿s tissue.The customer used the instrument release kit (irk) to open the instrument jaws.Then the customer removed the instrument with the cannula together since the instrument was stuck in the cannula.The customer used plier to shave the instrument shaft, straightened the wrist and pulled out the instrument from the cannula.The tip of the instrument was detached from the shaft.The procedure was completed with no reported injury.Isi followed up with the initial reporter and obtained the following additional information: the instrument and cannula were removed together because the instrument wrist came off from the shaft when the surgeon was using the instrument to pull out the tissue.Port incision was not increased to remove the instrument and cannula together.The instrument jaws were grasping the tissue, but no tissue was stuck on the jaws when the issue occurred since irk was used to open the jaws.The instrument pin was not loose, dislodged or missing.No fragment fell into the patient.The customer used a backup cannula to resolve the issue.The system initially powered on without errors.The surgeon did not disable or discontinue the use of the universal surgical manipulator (usm).The procedure was completed robotically with all four usms.

Manufacturer Narrative

Intuitive surgical, inc.(isi) has received the instrument, however, failure analysis has not completed their investigation.A follow-up mdr will be submitted when failure analysis has completed their investigation.

Manufacturer Narrative

The fenestrated bipolar forceps instrument was analyzed and found to have a broken main tube.A piece measuring proximately 0.1195¿ x 0.107 was not returned with the instrument.Components adjacent to this broken main tube did not show damage.Additional observations related to the customer reported complaint: the instrument was found to have a segment of the conductor wire dislodged and sticking out from the distal clevis.A loop of wire was sticking out such that the wire protrudes above the outer surface of the main tube.The wire insulation was not damaged, and the instrument passed an electrical continuity test.Components adjacent to the dislodged wire did not show damage.This was caused by the broken main tube.For clarification, the instrument was found with a dislodged cable crimp from wrist control cable grip.As a result, the cables appeared to be broken but it was not.The cable crimp was captured inside the welded grip.Additional findings unrelated to the customer reported complaint states that the instrument had a charring and/or localized melting on the outer surface of one bipolar yaw pulley at the base of the grip.As a result of the damage, a section of the active electrode (grip) was exposed that would not normally be exposed.The instrument passed the electrical continuity test.Further, the instrument was found with a frayed grip cable at the grip hub, but the cable was not fully broken.The frayed cable strands stuck out the wrist.There were no evidence of discoloration or corrosion/contamination on the cables to indicate a reprocessing induced issue.The components surrounding the frayed cable did not exhibit abnormal sharp edges or damage that would have contributed to the cable fraying.The complaint was confirmed by failure analysis.

Event Description

Refer to h10/h11 for follow-up information.

• Brand Name: ENDOWRIST
• Type of Device: FENESTRATED BIPOLAR FORCEPS
• 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: izabel nielson ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 19210760
• MDR Text Key: 341387725
• Report Number: 2955842-2024-14018
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119808
• UDI-Public: (01)00886874119808(11)230727(10)K14230727
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K214095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/03/2024

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: 471205-17
• Device Catalogue Number: 471205
• Device Lot Number: K14230727 0369
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2024
• Initial Date Manufacturer Received: 04/03/2024
• Initial Date FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2023
• 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
• Patient Sex: Prefer Not To Disclose