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

Model Number 471172-17

Device Problem Thermal Decomposition of Device (1071)

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

Event Date 09/06/2022

Event Type  malfunction  

Event Description

It was reported that after a da vinci-assisted radical prostatectomy with lymphadenectomy surgical procedure, a burn was identified on the beige coating of the maryland bipolar forceps instrument.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the customer and obtained the following additional information.The instrument was inspected prior to use with no damage noted.No interoperative collisions occurred.The damage was identified after reprocessing the instrument.No image or procedure video are available for review.The customer stated no injury to the patient occurred.

Manufacturer Narrative

Intuitive surgical, inc.(isi) has not received the maryland bipolar forceps for evaluation.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if additional information is obtained.A review of the instrument log for the maryland bipolar forceps instrument (pn# 471172-17 lot# k10220203-0411) associated with this event has been performed.Per logs, the instrument was last used on (b)(6) 2022 on system (b)(4) for approximately 49 minutes.The alleged event occurred on the 10th use of the instrument with 4 uses remaining.No image or procedure video was provided for review.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.Implant date is blank because the product is not implantable.Pma/510(k) number and adverse event are not applicable.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the maryland bipolar forceps instrument involved with this complaint and completed the device evaluation.Failure analysis investigations confirmed the customer reported complaint.Failure analysis found the primary failure of yaw pulley thermal damage to be related to the customer reported complaint.The instrument was found to have thermal damage on the bipolar yaw pulley near the base of the grip.There was no damage observed on the conductor wire.The instrument passed electrical continuity.The root cause of this failure is attributed to mishandling / misuse.

• 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: 15591782
• MDR Text Key: 301623349
• Report Number: 2955842-2022-14525
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• 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: K10220203 0411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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 Age: 73 YR
• Patient Sex: Male
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic