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

Model Number 471172-16

Device Problem Arcing (2583)

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

Event Date 02/25/2022

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 with thermal damage at the yaw pulley.Black char marks were observed.Any material missing is likely to be thermal induced rather than mechanically induced.Root cause is attributed to the user.Failure analysis found the primary failure of thermal damage to the bipolar yaw pulley to be related to the customer reported complaint.The electrical continuity test still passed and there was no insulation damage observed to the conductor wire.Additional testing: bipolar energy cord was successfully connected to generator and instrument.Energy activation test was then conducted on system.Wet sponge was held between grips and began to smoke when energy pedal was pressed.No unintended energy leakage was observed.A review of the instrument log was performed.Per the review, the device was last used on the reported event date of (b)(6) 2022 on system (b)(4).The maryland bipolar forceps had 11 use remaining after the last use.A review of the site's complaint history identified no other complaints related to the instrument and/or this event.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 arced.The allegation could be related to the potential for 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.

Event Description

It was reported that during a da vinci-assisted prostatectomy surgical procedure, the maryland bipolar forceps instrument was arcing.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the customer and obtained additional information on 23-march-2022.The instrument was reportedly inspected prior to use with no issues identified, and an erbe generator was used.Arcing was confirmed between the jaws while grasping tissue and using bipolar energy.There was no reported injury.Additional information was requested but was unknown, including the following: how long the instrument was in use, what other instruments were in use, and if there was any instrument collision.

• 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: 14190859
• MDR Text Key: 299072088
• Report Number: 2955842-2022-11199
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119792
• UDI-Public: (01)00886874119792(10)K12210823
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2022
• 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: K12210823 0057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2021
• 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