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

Model Number 471172-17

Device Problems Thermal Decomposition of Device (1071); Arcing (2583)

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

Event Date 12/28/2023

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) has not received the da vinci product with an alleged issue to perform failure analysis.A follow-up mdr will be submitted if the product is returned and evaluated and/or if additional information is received.A review of the provided image was performed by an intuitive surgical, inc.(isi) failure analysis engineer (fae).No thermal damage was noted from the provided photo.

Event Description

It was reported that during a da vinci-assisted liver resection surgical procedure, the maryland bipolar forceps (mbf) sparked, and the mbf pulley cover had thermal damage.The customer opted to reuse the mbf instrument for a while, but the same issue reoccurred.The customer used a backup mbf instrument to continue with the procedure.No fragment fell inside the patient.The procedure was completing as planned with no reported injury.

Manufacturer Narrative

An 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 with no issue.The instrument did not collide with any energy instrument during procedure.The other instruments which were used when arcing event occurred were the fenestrated bipolar forceps instrument and tip-up fenestrated grasper instruments.An arcing appeared to originate from the maryland bipolar forceps instrument.The arc grounded in patient anatomy when the surgeon was performing cauterizing and coagulating.There was no patient injury.The customer replaced the maryland bipolar forceps instrument for safety.The surgeon believed the conductor wire malfunction was the cause of the arcing event.The maryland bipolar forceps instrument did not touch any staples, clips or sutures while being energized.The patient did not return to the hospital due to experiencing any post-surgical complications as a result of the arcing event.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the maryland bipolar forceps instrument involved with this complaint and completed the device evaluation.Failure analysis confirmed the reported complaint.The instrument was found to have charring and localized melting of both bipolar yaw pulleys, in the space between the grips.The instrument passed the electrical continuity test.

• 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: 18603386
• MDR Text Key: 334022901
• Report Number: 2955842-2024-10727
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119792
• UDI-Public: (01)00886874119792(11)230720(10)K10230720(91)0002
• 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: Other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 471172-17
• Device Catalogue Number: 471172
• Device Lot Number: K10230720 0412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2023
• 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