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 06/09/2022

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the maryland bipolar forceps instrument involved with this complaint and completed the device evaluation.Failure analysis investigation revealed that the instrument was found to exhibit thermal damage at the base of the grips on the yaw pulley.There was no damage to the conductor wire insulation.The instrument passed the electrical continuity test.The root cause is attributed to the user.A review of the instrument log for the maryland bipolar forceps instrument (pn# 471172-16 / lot# k10211213-0358) associated with this event has been performed.Per logs, the instrument was last used on (b)(6) 2022 on system (b)(4) for approximately 40 minutes.The alleged event occurred on the 2nd use of the instrument.No image or procedure video was provided for review.Based on the information available at this time, this complaint is being classified as a reportable event due to the following conclusion: it was alleged that the instrument exhibited signs indicative of thermal damage.At this time, it is unknown what caused the thermal damage to occur.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.Blank mdr fields: follow-up was attempted, but patient information was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.Field is blank because the product is not implantable.Information for the blank fields is not available.Fields are not applicable.

Event Description

It was reported that after a da vinci-assisted radical prostatectomy with lymphadenectomy surgical procedure completed with no reported injury, the maryland bipolar forceps instrument was found to be burned on the tip.There was no reported injury.Intuitive surgical, inc.(isi) attempted to obtain additional information via follow-up.However, no further details have been received as of the date of this report.

• 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: 15048303
• MDR Text Key: 296120769
• Report Number: 2955842-2022-13034
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119792
• UDI-Public: (01)00886874119792(10)K10211213
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/19/2022

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: 471172-16
• Device Catalogue Number: 471172
• Device Lot Number: K10211213 0358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/19/2022
• Initial Date FDA Received: 07/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2021
• 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
• Patient Sex: Male