MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; STAPLER 30

Model Number	470430-08
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the endowrist stapler 30 instrument involved with this complaint and completed the device evaluation.Failure analysis confirmed the primary failure of loose grip cable to be related to the customer reported complaint.The instrument was found to have a broken grip cable at the distal end.As a result, the other grip cable became loose.The broken cable segment that contains the crimp was missing.The root cause of this failure is attributed to a component failure.The stapler instrument was placed and driven on an in-house system.The stapler passed initialization.The instrument clamped, fired and unclamped without any issues.A review of the logs showed no errors.This instruments grip tips were not moving intuitively, i.E.They were not following the master tool manipulator (mtm) input commands smoothly.This was caused by the broken grip cable.The root cause of this failure is attributed to a component failure.Also, the instrument was found to have the yaw plate broken.The yaw plate web was bent outwards towards the fire cardan.The root cause of is typically associated with mishandling/misuse, such as excess force applied to the distal end of the instrument.The instrument was found to have a broken pivot pin.There was no missing material.The root cause of this failure is associated with mishandling/misuse.
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary lobectomy surgical procedure that the customer had issues with the cable popping out of the jaw hinge of the endowrist stapler 30 instrument.The procedure was completed with no patient harm.

• Brand Name: ENDOWRIST
• Common Device Name: STAPLER 30
• 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: 17015747
• Report Number: 2955842-2023-14875
• Device Sequence Number: 17860717
• Product Code: NAY
• UDI-Device Identifier: 00886874112700
• UDI-Public: (01)00886874112700(10)T10200604
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K152421
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 470430-08
• Device Catalogue Number: 470430
• Device Lot Number: T10200604 0018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/01/2021
• Initial Report FDA Received Date: 05/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2020
• 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: 71 YR
• Patient Sex: Male
• Patient Weight: 87 KG
• Patient Race: White