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 11/02/2021

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# n11210629 0066) associated with this event has been performed. Per logs, the instrument was last used for a procedure on (b)(6) 2021 using system sl0100. The instrument had 11 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 surgical procedure, the customer noticed a color change on the light colored plastic on the maryland bipolar forceps instrument. The 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 a thermal damage was observed. The issue was identified during central processing. Further details were not provided.

• 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: 13086210
• MDR Text Key: 286492291
• Report Number: 2955842-2021-11817
• Device Sequence Number: 1
• Product Code: NAY
• 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

• Date FDA Received: 12/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 471172-16
• Device Catalogue Number: 471172
• Device Lot Number: N11210629 0066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 03/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2021
• 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 Treatment Data

Date Received: 12/26/2021 Patient Sequence Number: 1

Treatment

DA VINCI INSTRUMENTS AND ACCESSORIES