MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; MARYLAND BIPOLAR FORCEPS

Model Number 420172-17

Device Problems Thermal Decomposition of Device (1071); Material Split, Cut or Torn (4008)

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

Event Date 11/24/2021

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted radical prostatectomy surgical procedure, the bipolar energy was not working on the maryland bipolar forceps instrument.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) obtained the following information from the customer about the complaint: firstly this instrument was billed to (b)(6) hospital, however, (b)(6) hospital need a maryland bipolar forceps instrument immediately so (b)(6) hospital gave (b)(6) hospital the instrument to use.The maryland bipolar forceps instrument did not work so they returned the instrument back to (b)(6) hospital.For this reason, a new bill to (b)(6) hospital was not prepared.The instrument belonged to (b)(6) hospital.We wrote (b)(6) hospital for both incidents because of this reason.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the maryland bipolar forceps instrument involved with this complaint and completed the device evaluation.Failure analysis (fa) investigations confirmed the reported complaint.For clarification, the instrument failed the electrical continuity test because of a broken conductor wire at the bipolar insert junction of the back-end of the instrument.As a result, energy activation would not work when activated on the system.Root cause of broken conductor wire is attributed to a manufacturing and component issue.Additional observation fa found related to the reported complaint: thermal damage was observed at the bipolar insert junction where it connected with the conductor wire which was found broken off.Root cause of thermal damage of bipolar insert was not established.Black char marks were observed.Additional observation fa found that was not related to the reported complaint: signs of corrosion/contamination were found on the instrument bearings upon housing removal.Input disk bearings exhibit brownish-orange discoloration.Improper cleaning during reprocessing most commonly causes this failure.Signs of excessive residue were found on the instrument clamping pulleys upon housing removal.Improper cleaning during reprocessing most commonly causes this failure.No images or videos were shared for the event.A review of the device logs for the maryland bipolar forceps (part# 420172-17 | lot# n10210705-053) 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 (b)(4).There were 8 uses remaining after this last usage.This complaint is considered a reportable event due to the following conclusion: failure analysis found the maryland bipolar forceps instrument had conductor wire damage.The damaged/broken conductor wire has potential for electrical discharge at a location other than intended.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

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

Additional evaluation was performed and the initial findings were confirmed.A closer look was taken at the broken conductor wire and the thermal damage at the bipolar insert.The thermal damage likely occurred due to some kind of shorting.The root cause of this is attributed to manufacturing due to the instrument having 8 lives left and the broken conductor wire in the proximal end.

• Brand Name: ENDOWRIST;DAVINCI SI
• 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: 15033028
• MDR Text Key: 296040922
• Report Number: 2955842-2022-12975
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874111475
• UDI-Public: (01)00886874111475(10)N10210705
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K050369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/15/2022

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: 420172-17
• Device Catalogue Number: 420172
• Device Lot Number: N10210705 053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2022
• Initial Date Manufacturer Received: 06/15/2022
• Initial Date FDA Received: 07/15/2022
• Supplement Dates Manufacturer Received: 07/19/2022
• Supplement Dates FDA Received: 08/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2021
• 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