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 09/20/2022

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the maryland bipolar forceps involved with this complaint and completed the device evaluation.Failure analysis replicated and confirmed the reported complaint.Failure analysis found the primary failure of bipolar yaw pulley thermal damage to be related to the customer reported complaint.The bipolar yaw pulley exhibits localized melting damage at the base of one of the grip tips.Electrical continuity was performed and passed.No damage to the conductor wire was observed.The root cause of this failure was typically attributed to mishandling or misuse.A review of the device logs for the maryland bipolar forceps (part# 471172-16/ lot# k10211206 - 0203) associated with this event has been performed.Per this review of the logs, the maryland bipolar forceps was last used on (b)(6) 2022 via system serial# (b)(4).There were 4 uses remaining after this last usage.This last usage of the device per the log review matches the reported event date, indicating that the instrument was not used after the date of the reported event.No image or video clip for the reported event was submitted for review.Based on the information provided at this time, this complaint is being reported due to the following conclusion: it was alleged that the maryland bipolar forceps bipolar yaw pulley exhibits localized melting damage at the base of one of the grip tips.The cause of this failure was typically attributed to the user mishandling or misuse.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 not applicable because the product is not implantable.Pma/510(k) number and adverse event are not applicable.

Event Description

It was reported that during a da vinci-assisted prostatectomy surgical procedure, the customer reported that the base of the maryland bipolar forceps (mbf) instrument had a burnt mark.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up on (b)(6) 2022 and obtained the following additional information: the thermal damage was identified after reprocessing.The customer stated that it was not clear if there was any damage on the instrument after the last procedure.There was no patient injury.

• 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: 15685983
• MDR Text Key: 302558800
• Report Number: 2955842-2022-14903
• 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: JA
• 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: 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 0203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2022
• 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 Sex: Male