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

Model Number 470205-17

Device Problem Thermal Decomposition of Device (1071)

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

Event Date 03/18/2022

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the fenestrated bipolar forceps instrument involved with this complaint and completed the device evaluation.Failure analysis investigations did not replicate nor confirm the customer reported complaint.The instrument was placed and driven on an in-house system.The instrument passed the recognition and engagement tests.The instrument moved intuitively with a full range of motion in all directions.The grips opened and closed properly.The instrument was fully functional.A review of the logs found no failures.There was no problem detected.There were additional observations not reported by the site and not related to the primary failure.The instrument was found to have a segment of the conductor wire dislodged from the connector at the back end.The wire insulation was not damaged.The root cause of this failure is attributed to a component failure.The instrument was found to have thermal damage on the bipolar yaw pulley.The conductor wire was not found broken or with damaged insulation.The root cause of this failure is attributed to mishandling/misuse.A review of the instrument log showed the fenestrated bipolar forceps instrument (part# 470205-17 / lot# n10210510-0024) was last used on (b)(6) 2022 during a procedure with system sk4299.The fenestrated bipolar forceps instrument had 8 uses remaining.This last usage of the device was before the reported event date.Images of the fenestrated bipolar forceps instrument related to this event were received.A review of the submitted images was performed by the regulatory post market surveillance (rpms) specialist.One of the images showed the instrument with obvious damage at the bipolar yaw pulley.No conclusive determination can be made based on this analysis.In addition, failure analysis investigations found thermal damage on the instrument bipolar yaw pulley, which is likely related to the damage identified in the provided image.This complaint is being reported due to the following conclusion: failure analysis investigations found thermal damage on the instrument bipolar yaw pulley.The failure analysis finding could be related to the potential for electrical discharge at a location other than intended.While there was no patient injury reported, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.Follow-up was attempted, but the patient information was either unknown, unavailable, not provided, or not applicable.Device expiration date was left blank.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 prior to the start of a da vinci-assisted surgical procedure, the fenestrated bipolar forceps instrument could not be identified.The customer replaced the fenestrated bipolar forceps instrument with a back-up instrument of the same kind and completed the procedure with no reported injury.Intuitive surgical, inc.(isi) performed follow-up and obtained the following additional information regarding the reported event: the instrument was not recognized prior to this reported procedure.Therefore, it was not inserted inside the patient's body.There was no arcing noted during the instruments last usage on procedure date (b)(6) 2022, and it was confirmed that there was no patient harm, injury or adverse outcome.

• Brand Name: ENDOWRIST
• Type of Device: FENESTRATED 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: 15210470
• MDR Text Key: 297705058
• Report Number: 2955842-2022-13400
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112359
• UDI-Public: (01)00886874112359(11)210506(10)N10210510
• 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,Foreign
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 07/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470205-17
• Device Catalogue Number: 470205
• Device Lot Number: N10210510 0024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2022
• Date Manufacturer Received: 07/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2021
• 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.