MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; BIPOLAR GRASPER, LONG

Model Number 471400-10

Device Problem Thermal Decomposition of Device (1071)

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

Event Date 09/05/2022

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) has not received the long bipolar grasper instrument 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.No image or video clip for the reported event was submitted to isi for review.A review of the instrument log for the long bipolar grasper (pn 471400-10/lot # k10210913-0103) associated with this event was performed.Per logs, the instrument was last used on (b)(6) 2022 on system sl0642.The instrument had seven uses remaining after last use.This complaint is being reported 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 the patient information was either unknown, unavailable, not provided, or not applicable.Device expiration date was left blank.Implant date is blank 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 - radical with lymphadenectomy surgical procedure, one jaw of the long bipolar grasper instrument was burned.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) made multiple follow up attempts to obtain additional information, however, no further details have been received as of date of this report.

Manufacturer Narrative

Based on the claim against the product by the customer noting burned jaw, an investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) received a da vinci product to perform failure analysis.The long bipolar grasper instrument was analyzed and found to have thermal damage on the bipolar yaw pulley.As a result, the electrode was exposed.The instrument passed the electrical continuity test.The complaint regarding burned jaw was confirmed by failure analysis, which indicates that the device did contribute to the customer reported issue.The probable root cause of thermal damage is attributed to carbonized tissue on the grips of this bipolar instrument creating a conductive path during use.Thermal damage can also result due to inadvertent energy application from a monopolar instrument.

Event Description

Refer to h10/h11 for follow-up information.

• Brand Name: ENDOWRIST
• Type of Device: BIPOLAR GRASPER, LONG
• 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: 15601970
• MDR Text Key: 301712331
• Report Number: 2955842-2022-14562
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874121528
• UDI-Public: (01)00886874121528(10)K10210913
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K214095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 471400-10
• Device Catalogue Number: 471400
• Device Lot Number: K10210913 0103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2021
• 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