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

Model Number 471172-16

Device Problem Thermal Decomposition of Device (1071)

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

Event Date 01/28/2022

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted partial nephrectomy surgical procedure, the maryland bipolar forceps instrument had a torn cable.The procedure was completed with no reported injury.The maryland bipolar forceps is a multiple-use electrosurgical endoscopic instruments with a grasping tip to be used in conjunction with the da vinci system and an external electrosurgical unit (esu).The instrument is designed to provide energy from the designated location on the instrument (the tip) to the planned anatomical location when used as intended.The energy is activated by pressing the designated pedal on the surgeon side console (ssc).Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the maryland bipolar forceps instrument was inspected prior to use.The color of the broken instrument cable is unknown.There was no patient injury and no fragment fell into the patient.

Manufacturer Narrative

Isi received the maryland bipolar forceps instrument involved with this complaint and completed the device evaluation.Failure analysis (fa) investigation confirmed the customer reported complaint.Fa found the primary failure of the broken conductor wire to be related to the customer reported complaint.The maryland bipolar forceps instrument was found to have a broken conductor wire at the yaw pulley and the conductor wire was broken at the grip-crimp location.The instrument failed the electrical continuity test.The root cause of this failure is attributed to a component failure.Additional observation related to the customer reported complaint was also identified: the maryland bipolar forceps instrument was found to have a thermal damage on the bipolar yaw pulley.The thermal damage was observed to be near the base of the yaw pulley.There was no damage found on the conductor wire and the conductor wire was found broken near the location of the thermal damage.The root cause of this failure is attributed to mishandling/misuse.A review of the instrument log for the maryland bipolar forceps (part number 471172-16/lot number n12210607-0034) associated with this event has been performed.Per logs, the maryland bipolar forceps instrument was last used in a procedure on (b)(6) 2022 via system sk3315.The alleged instrument had 5 uses remaining after the last procedural use.No image or video of the procedure was provided for review.This complaint is considered a reportable malfunction event due to the following conclusion: the maryland bipolar forceps instrument had conductor wire damage.Thermal damage at or near a conductor wire breakage is evidence of electrical discharge at a location other than intended.While there was no harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.

• Brand Name: ENDOWRIST
• Type of Device: MARYLAND BIPOLAR FORCEPS
• 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: 14978279
• MDR Text Key: 295628942
• Report Number: 2955842-2022-12919
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119792
• UDI-Public: (01)00886874119792(10)N12210607
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K131861
• 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: 06/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 471172-16
• Device Catalogue Number: 471172
• Device Lot Number: N12210607 0034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2022
• Date Manufacturer Received: 06/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2021
• 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