MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; DOUBLE FENESTRATED GRASPER

Model Number	420189-11
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary segmentectomy surgical procedure, the robotic instrument tip articulated and dangled.Surgeon had to cut the tip off of it in order to remove it out of the patient.Instrument fragments reportedly fell inside the patient, but all pieces were retrieved without injury.The procedure was completed as planned with no reported injury.On 23-feb-2022, intuitive surgical, inc (isi) received user facility report (b)(4) stating: "robotic instrument tip articulated and dangled.Surgeon had to cut the tip off of it in order to remove it out of the patient.All pieces were retrieved without injury." on (b)(6) 2022, isi spoke to the risk manager and obtained the following information: the part number was 420189-11 and it was for a double fenestrated grasper instrument.She did not know where the instrument was currently, but will look around to see if it is in the risk management office (she returns in the office later this week).There was no mention of the instrument colliding with another instrument or with a hard object inside the patient.The surgeon was articulating the instrument when it broke.She did not know if the instrument was inspected before use, because she was not there.She was unsure how long the instrument was in use before the instrument broke.The fragment was retrieved in the same procedure, but she did not know what type of instrument retrieved the fragment.There was no post operative tests performed to check for remaining fragments.The procedure was completed robotically.On 09-mar-2022 the risk manager stated she checked with the operating room and materials management and they do not have the instrument or fragment so she is unable to return the items back to isi.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has not yet received the double fenestrated grasper instrument for evaluation, therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if the instrument is returned (post failure analysis evaluation) or if additional information is received.A review of the instrument log of the double fenestrated grasper (part # 420189-11; / lot # n10190128-547) associated with this event has been performed.Per the logs, the instrument was last used on (b)(6) 2021 on system sh1182.The alleged event occurred on the 9th use of the instrument.A review of the site's complaint history does not show any additional complaints for this product.No image or procedure video was provided for review.This complaint is being reported due to the following conclusion: it was alleged during a da vinci-assisted pulmonary segmentectomy surgical procedure, the surgeon had to cut the damaged tip off a double fenestrated grasper instrument to remove it from the patient.Instrument fragments reportedly fell inside the patient, and all fragments were retrieved successfully during the same procedure.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: DOUBLE 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: 13887598
• Report Number: 2955842-2022-10749
• Device Sequence Number: 991390
• Product Code: NAY
• UDI-Device Identifier: 00886874111581
• UDI-Public: (01)00886874111581(10)N10190128
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K050369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Risk Manager
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 420189-11
• Device Catalogue Number: 420189
• Device Lot Number: N10190128 547
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/23/2022
• Initial Report FDA Received Date: 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 74 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White