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 06/22/2022

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted benign hysterectomy surgical procedure, a thermal damage on the maryland bipolar forceps (mbf) insulator was noted.The procedure was completing as planned with no reported injury.Isi followed up with the initial reporter and obtained the following additional information: the thermal damage was identified after the reprocessing.When the instrument was last used during the procedure, the instrument was not inspected prior to use and after the completion of the procedure.It was unknown if the instrument collided with any other instrument or tool during the procedure.No arcing was observed.There was no patient injury.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the maryland bipolar forceps instrument involved with this complaint and completed the device evaluation.Failure analysis found the primary failure of thermal damage to the bipolar yaw pulley to be related to the customer reported complaint.For clarification, the instrument was found to have thermal damage on the bipolar yaw pulley.Upon visual inspection, the conductor wires exhibit no damage and passed the electrical continuity test.The root cause of this failure is attributed to mishandling/misuse.As of 01-aug-2022, a review of the site's complaint history does not reveal any related or duplicate complaints involving this product and/or this event.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 were 10 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.Failure analysis found the primary failure of thermal damage to the bipolar yaw pulley attributed to mishandling/misuse.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: 15303396
• MDR Text Key: 298709334
• Report Number: 2955842-2022-13694
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119792
• UDI-Public: (01)00886874119792(10)K10211202
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 07/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2022
• 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: K10211202 0376
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2022
• Date Manufacturer Received: 07/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2021
• 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: Female