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

Model Number 471172-16

Device Problems Thermal Decomposition of Device (1071); Material Split, Cut or Torn (4008)

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

Event Date 08/01/2022

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted partial nephrectomy surgical procedure, the maryland bipolar forceps instrument had no issue with movement, but the bipolar function did not work.A backup instrument of a different kind was used to continue the procedure.The procedure was completed with no report of patient injury.Intuitive surgical, inc.(isi) followed up with the initial reporter to obtain the information regarding patient relevant testing and medical history; however, the reporter was not able to provide that 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 replicated and confirmed the customer reported complaint.Failure analysis found the primary failure of broken conductor wire to be related to the customer reported complaint.The instrument was found to have a broken conductor wire at the grip-crimp location at the distal end within the insulation.The instrument failed the electrical continuity test.The grip tips were manually manipulated and intermittently passed continuity.No insulation damage on the conductor wire was observed.The root cause of this failure is attributed to a component failure.Additional observation not reported by site was that the instrument was found to have thermal damage on the bipolar yaw pulley.The bipolar yaw pulley exhibited localized melting damage at the base of one of the grip tips.Root cause of this failure is attributed to mishandling/misuse.A review of the instrument log for the maryland bipolar forceps instrument (part# 471172-16| lot/serial# (b)(4)) associated with this event has been performed.Per this review of the logs, the maryland bipolar forceps instrument was last used on (b)(6) 2022.No image or procedure video was provided for review.This complaint is being reported based on the following conclusion: failure analysis confirmed thermal damage at the grip base of the yaw pulley, which 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.Blank mdr fields: follow-up was attempted, but the 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.

• 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: 15686105
• MDR Text Key: 302558542
• Report Number: 2955842-2022-14902
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119792
• UDI-Public: (01)00886874119792(10)K10211206
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2022
• 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: K10211206 0364
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2021
• 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 Age: 49 YR
• Patient Sex: Female
• Patient Weight: 72 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian