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

Model Number 470172-16

Device Problems Thermal Decomposition of Device (1071); Defective Device (2588)

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

Event Date 01/07/2022

Event Type  malfunction  

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 confirmed the customer reported complaint.Fa found the primary failure of thermal damage to the bipolar yaw pulley to be related to the customer reported complaint.The instrument was found to have thermal damage on the bipolar yaw pulley.The instrument passed the electrical continuity and energy delivery tests.The root cause of this failure is attributed to mishandling/misuse.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) 2021 via system serial# (b)(4).There were 2 uses remaining after this last usage.No usage logged on the documented event date of (b)(6) 2022.This complaint is a reportable malfunction due to the following conclusion: thermal damage to the bipolar yaw pulley is evidence of 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.Blank mdr fields: follow-up was attempted, but the patient information in, i.E patient race, ethnicity, relevant tests, results, and patient medical history were not provided.The expiration date is not applicable.Implant date is blank because the product is not implantable.Pma/510(k) number and adverse event are not applicable.

Event Description

It was reported that after a da vinci-assisted surgical procedure, the maryland bipolar forceps instrument was observed to be defective.The procedure was completed with no reported injury.Follow-up attempts have been made to obtain additional information from the customer concerning the reported event; however, no information was provided at this time.

• 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: 15255062
• MDR Text Key: 298193146
• Report Number: 2955842-2022-13516
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112281
• UDI-Public: (01)00886874112281(10)N10201006
• Combination Product (y/n): N
• PMA/PMN Number: K131861
• 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
• Report Date: 07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2022
• 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: N10201006 0082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2022
• Date Manufacturer Received: 07/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2020
• 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.