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

Model Number 471172-17

Device Problems Thermal Decomposition of Device (1071); Arcing (2583)

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

Event Date 07/15/2022

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted prostatectomy - radical w/ lymphadenectomy surgical procedure, the insulator of the maryland bipolar forceps (mbf) instrument was burnt and damaged.The procedure was completed with no reported injury.The maryland bipolar forceps is a multiple-use electrosurgical endoscopic instruments with a grasping tip to be used in conjunction with the da vinci system and an external electrosurgical unit (esu).The instrument is designed to provide energy from the designated location on the instrument (the tip) to the planned anatomical location when used as intended.The energy is activated by pressing the designated pedal on the surgeon side console (ssc).Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the instrument was inspected prior to use with no issue.It was unknown if the instrument collided with the other instrument or tool during the procedure.There was arcing when the monopolar curved scissors (mcs) was activated.Thermal damage was noted after the arcing event.The surgeon suspected that the cause of the arcing event was due to close distance to the mcs.There was no injury to the patient.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the maryland bipolar forceps instrument involved with this complaint and completed the device evaluation.Failure analysis (fa) investigation confirmed the customer reported complaint.The maryland bipolar forceps instrument was found with thermal damage at the yaw pulley and black char marks were observed at the grip base.Any material missing likely to be thermally induced rather than mechanically induced.The root cause is attributed to mishandling/misuse.Fa 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 pass and there was no insulation damage observed to the conductor wire.No image or video was available for review.A review of the site's complaint history found this complaint to be related to patient identifier# (b)(6), which was created to document the monopolar curved scissors (mcs) instrument arcing.A review of the device logs for the maryland bipolar forceps (part number 471172-17/lot number k10220203 - 0204) involved with this event has been performed.Per this review of the logs, the maryland bipolar forceps instrument was last in a procedure on (b)(6) 2022 via system (b)(4).The alleged instrument had 7 uses remaining after this last usage.This complaint is considered a reportable malfunction due to the following conclusion: it was alleged that the maryland bipolar forceps instrument exhibited signs indicative of thermal damage.The damage at the site of the grip base has 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.

• 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: 15271901
• MDR Text Key: 298371432
• Report Number: 2955842-2022-13611
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119792
• UDI-Public: (01)00886874119792(10)K10220203
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 07/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2022
• 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 0204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2022
• Date Manufacturer Received: 07/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2022
• 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
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian