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 11/30/2021

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) has not yet received the maryland bipolar forceps 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 the product is received for testing and/or if additional information is received.A review of the device logs for the maryland bipolar forceps (part# 471172-16 | lot/serial# (b)(4)) associated with this event has been performed.Per this review of the logs, the maryland bipolar forceps was last used on (b)(6) 2021 via system serial# (b)(4).There were 12 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.A review of the site's complaint history does not show any additional complaints related to this product or this event.No image or video clip for the reported event was available for review.A system log review was performed, but no errors related to this event would exist in the logs.This complaint is considered a reportable malfunction due to the following conclusion: it was alleged that the instrument exhibited signs indicative of thermal damage with no evidence or claim of user mishandling or misuse.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.

Event Description

It was reported that after a da vinci-assisted prostatectomy procedure, the insulation cover of the maryland bipolar forceps turned black.The procedure was completed as planned 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 the date of this report.

Event Description

Refer to mfrnarrative for follow-up information.

Manufacturer Narrative

The instrument was further evaluated by advanced failure analysis team.The cable entry point to the maryland bipolar forceps instrument jaw closest to the site of the thermal damage was also inspected.The silicone potting exhibited no damage and the wire was securely attached.

Manufacturer Narrative

Additional information can be found in the following fields: d9, g3, g6, h2, h3, h6, and h10.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information on 25-jan-2022: the instrument was inspected prior to use and no abnormality was found.It was unknown if the instrument collided with any other instrument or tool during the procedure.It was also unknown if the instrument was inspected for damage after the procedure was completed or prior to reprocessing.The customer found the issue after reprocessing.The internal wire was not exposed.There was no arcing or thermal damage that occurred when the instrument was in use.D11- intuitive surgical, inc.(isi) received the maryland bipolar forceps involved with this complaint and completed the device evaluation.Failure analysis replicated and confirmed the customer reported complaint.Failure analysis found the primary finding of yaw pulley thermal damage to be related to the customer reported complaint.The instrument was found to have thermal damage on the bottom side of the yaw pulley for the left jaw.The root cause of this failure is attributed to user mishandling/misuse.D02- an additional finding related to the customer reported complaint was also identified.The instrument was found to have conductor wire insulation damage.The insulation damage was aligned with the thermal damage on the yaw pulley.There was no material missing and the electrical continuity test passed.The electrical wires were not exposed.The root cause of this failure is attributed to a component failure.

Event Description

Refer to h10/h11 for follow-up information.

• 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: 13159578
• MDR Text Key: 283232421
• Report Number: 2955842-2022-10006
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119792
• UDI-Public: (01)00886874119792(10)K10210621
• 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,Followup,Followup
• Report Date: 12/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2022
• 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: K10210621 0044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2022
• Date Manufacturer Received: 06/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2021
• 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