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

Model Number 470172-16

Device Problem Thermal Decomposition of Device (1071)

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

Event Date 06/22/2022

Event Type  malfunction  

Manufacturer Narrative

An rma has been issued to the customer requesting to have the instrument returned; however, isi has not yet received the maryland bipolar forceps for evaluation.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if additional information is obtained.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.No photo or video was provided by the site for review.A review of the device logs for the maryland bipolar forceps (part# 470172-16 | 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) 2022 via system serial# (b)(4).There were 7 uses remaining after this last usage.This complaint is considered a reportable malfunction due to the following conclusion: it was alleged that the instrument exhibited signs indicative of thermal damage.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 during central processing, it was noted that the maryland bipolar forceps instrument was noted to have burnt plastic.The procedure was completed with no reported injury or delay.Intuitive surgical (is) contacted the site to obtain additional information regarding this event.However, no additional details have been received as of the date of this report.

Manufacturer Narrative

Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the instrument was inspected prior to the procedure and no anomalies were observed.The instrument did not collide with any other instrument.The thermal damage was observed on the grey plastic of the instrument.The damage was noted after the procedure during sterilization.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the maryland bipolar forceps instrument involved with this complaint and completed the device evaluation.Failure analysis (fa) investigation replicated and confirmed the customer reported complaint.Fa found the primary failure of bipolar yaw pulley thermal damage with exposed electrode to be related to the customer reported complaint.The instrument was found to have thermal damage on the bipolar yaw pulley.The bipolar yaw pulley exhibited localized melting damage at the base of one of the grip tips with an exposed electrode.Electrical continuity was performed and passed.No damage to the conductor wire was observed.The root of this failure is attributed to mishandling/misuse.An additional observation not reported by the site was also identified.The instrument was found to have various scratch marks with light material removed on the main tube.The scratch marks were 0.072¿ - 0.160¿ in length and were not aligned with the tube axis.Common causes of the failure mode scratch marks /abrasions on the instrument main tube are typically attributed to mishandling/misuse.Scratches or abrasions to the main tube of instruments are deemed cosmetic damage.The probable root cause of these scratches or abrasions is attributed to damage during use, which can result from instrument collisions, abrasive instrument cleaning, instrument cleaning inside the body, or normal wear over time due to friction against cannula.

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: 15557994
• MDR Text Key: 301324466
• Report Number: 2955842-2022-14444
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112281
• UDI-Public: (01)00886874112281(10)N11191125
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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,Followup
• Report Date: 09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470172-16
• Device Catalogue Number: 470172
• Device Lot Number: N11191125 0003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 01/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2019
• 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