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 03/30/2022

Event Type  malfunction  

Event Description

It was reported that during central processing, the customer conducted an inspection and observed thermal damage on the pulley cover of the maryland bipolar forceps instrument.No patient involvement.Intuitive surgical, inc.(isi) followed up with the site and obtained the following additional information regarding the reported event: there was no issue with the instrument related to thermal damage, unintended energy discharge, arcing and no known inadvertent contact with another energy instrument during the last procedure usage on (b)(6) 2022 using system (b)(4).No conductor wire damage was confirmed upon inspection.

Manufacturer Narrative

Concomitant medical products- intuitive surgical, inc.(isi) received the maryland bipolar forceps (mbf) instrument involved with this complaint and completed the device evaluation.The reported event was confirmed through failure analysis (fa) investigation.The instrument was found to have thermal damage at the bipolar yaw pulley.Black char marks were observed.Investigation indicated that any material missing is likely to be thermally induced rather than mechanically induced.No insulation damage observed to the conductor wire.The instrument was tested for electrical continuity and passed.The known cause of the observed thermal damage at the bipolar yaw pulley is attributed to instrument mishandling and misuse.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.A review of the submitted image was performed by an isi failure analysis engineer (fae).The following additional information was provided: no clear damage on the maryland bipolar forceps instrument grips or conductor wire can be visualized.A conclusive determination could not be made based on this analysis.A review of the instrument log for the maryland bipolar forceps instrument (part# 471172-16 / lot# k10211012-0524) associated with this event has been performed.Per logs, the instrument was last used for a prostatectomy - radical w/o lymphadenectomy procedure on (b)(6) 2022 on system (b)(4).The instrument has 11 remaining usable lives with no subsequent use recorded.This complaint is considered a reportable event due to the following conclusion: it was alleged that the instrument exhibited signs indicative of thermal damage.Fae's analysis of the submitted image was inconclusive.Fa investigation confirmed thermal damage at the bipolar yaw pulley.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: 14257607
• MDR Text Key: 290470593
• Report Number: 2955842-2022-11361
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119792
• UDI-Public: (01)00886874119792(10)K10211012
• 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: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2022
• 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: K10211012 0524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2022
• Date Manufacturer Received: 03/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2021
• 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