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 09/22/2021

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) has requested that the maryland bipolar forceps (mbf) instrument be returned for evaluation, but it has not yet been returned.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 returned and evaluated and/ or if additional information is received.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.No image or video was provided for review.A review of the instrument log for the mbf instrument (part# 471172-16/lot# n10210419 0480) associated with this event has been performed.Per logs, the instrument was last used for a procedure on (b)(6) 2021 using system sl0101.The instrument had 6 remaining usable lives with no subsequent use recorded.This complaint is being reported based on 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 radical prostatectomy with lymphadenectomy procedure, while in sterilization, the customer noticed the plastic in the joint of the maryland bipolar forceps instrument was darkened.The surgical procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and on 09-dec-2021, obtained the following additional information: it is unknown if thermal damage was observed during the procedure.The issue was identified during central processing.Further details were not provided.

Manufacturer Narrative

D11-intuitive surgical, inc.(isi) has received the maryland bipolar forceps instrument associated with this complaint and completed investigations.Failure analysis investigations confirmed the customer reported complaint that the "plastic in joint darkened".The instrument was found to have thermal damage on the yaw pulley.Failure analysis found no damage to the conductor wire or to the conductor wire insulation.The instrument passed an electrical continuity test.The root cause of this failure is attributed to mishandling/misuse.

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: 13086198
• MDR Text Key: 286492520
• Report Number: 2955842-2021-11816
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119792
• UDI-Public: (01)00886874119792(10)N10210419
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: N10210419 0480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 12/02/2021
• Initial Date FDA Received: 12/26/2021
• Supplement Dates Manufacturer Received: 03/22/2022
• Supplement Dates FDA Received: 04/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2021
• 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