MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; TIP-UP FENESTRATED GRASPER

Model Number 470347-11

Device Problem Break (1069)

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

Event Date 01/20/2022

Event Type  malfunction  

Event Description

It was reported during a da vinci-assisted surgical procedure, the instrument shaft and joint broke.The site replaced the instrument and completed the procedure as planned with no report of patient harm, adverse outcome or injury.Intuitive surgical, inc.(isi) followed up with the customer and obtained additional information related to the event.There were no fragments that fell into the patient in question.The end of the instrument had bent in such a way that the instrument could not be removed from the metal trocar.The problem was found when the pa went to remove the instruments because the procedure was done and dr.(b)(6) said it was time to undock the robot and the instruments.When the pa went to remove the instrument, it was stuck and she was able to successfully remove the instrument with the trocar at the same time.There were no fragments that fell into the patient.The instrument and trocar were passed off the field so they could be removed.The only way the trocar could come off the instrument was to continue peeling the sides of the instrument shaft.There was no report of the patient returning to the hospital due to any experienced post-surgical complication related to the broken instrument.The instrument was never retained inside the patient.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the tip-up fenestrated grasper instrument and performed a device evaluation.Failure analysis confirmed the reported issue.The instrument was found to have the main tube broken.A piece measuring proximately 0.187¿ x 0.112¿ was not returned with the instrument.The root cause of broken instrument main tube is typically attributed to mishandling/misuse.The following was found during the device evaluation, but was not related to the reportable finding: the instrument was found to have various scratch marks with light material removed on the main tube.The scratch marks were 0.100¿ - 0.212¿ in length and were not aligned with the tube axis.The root cause of scratch marks /abrasions to the instrument main tube is typically attributed to mishandling/misuse.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.A review of the device logs for the tip-up fenestrated grasper (part# 470347-11 | lot-sequence# n10201027-0100) associated with this event has been performed.Per this review of the logs, the tip-up fenestrated grasper was last used on (b)(6) 2022 during a pulmonary lobectomy on system serial# (b)(4).No image or video clip for the reported event was submitted for review.This complaint is considered a reportable event due to the following conclusion: failure analysis acknowledges that a fragment was missing from a portion of the device that enters the patient.Based on the information provided, there was no report from the customer that a fragment from the instrument fell into the patient during the procedure.While there was no report of harm or injury to the patient and no report of fragments falling into the patient, the reported failure mode could likely cause or contribute to an adverse event if the fragment(s) did fall into the patient.

• Brand Name: ENDOWRIST
• Type of Device: TIP-UP FENESTRATED GRASPER
• 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: 14046383
• MDR Text Key: 298476033
• Report Number: 2955842-2022-10924
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112496
• UDI-Public: (01)00886874112496(10)N10201027
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470347-11
• Device Catalogue Number: 470347
• Device Lot Number: N10201027 0100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2020
• 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
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Ethnicity: Hispanic
• Patient Race: White