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 08/03/2022

Event Type  malfunction  

Event Description

It was reported that during central processing, a scorched tip of the maryland bipolar forceps (mbf) instrument was noted.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the thermal damage was identified during central processing.In the procedure, when the instrument was last in use, the instrument was not inspected prior to use or after the procedure.The instrument did not collide with any other instrument or tool.There was no arcing seen, and there was no patient injury.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the maryland bipolar forceps (mbf) involved with this complaint and completed the device evaluation.Failure analysis found that there was charring and localized melting at the grip base between the grips.The instrument passed the electrical continuity test.No damage to the conductor wire was observed.The root cause of this failure was typically attributed to mishandling or misuse, most commonly caused by insulation degradation and carbonized tissue creating a conductive path.Failure analysis found the secondary failure of bipolar yaw pulley thermal damage to be related to the customer reported complaint.The bipolar yaw pulley exhibited localized melting damage at the base of one of the grip tips.The root cause of this failure was attributed to mishandling or misuse.Additional observation, which was not reported by site, was that the instrument was found to have various scratch marks on the main tube.The scratch marks were 0.128¿ - 0.171¿ in length and were not aligned with the tube axis.The root cause of this failure was attributed to mishandling or misuse.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) 2022 via system serial# (b)(4).There was 1 use 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.No image or procedure video was provided for review.Based on the information available at this time, this complaint is being classified as a reportable event 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.

• 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: 15397813
• MDR Text Key: 299657199
• Report Number: 2955842-2022-13934
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119792
• UDI-Public: (01)00886874119792(10)K12210921
• 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
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/11/2022

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: 471172-16
• Device Catalogue Number: 471172
• Device Lot Number: K12210921 0094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2022
• Initial Date Manufacturer Received: 08/11/2022
• Initial Date FDA Received: 09/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2021
• 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