MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; STAPLER 45

Model Number	470298-12
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted colostomy closure surgical procedure, a wire was sticking out of the stapler 45.The procedure was completed with no reported injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the stapler 45 involved with this complaint and completed the device evaluation.Failure analysis investigations replicated and confirmed the customer reported complaint.Failure analysis found the primary failure of broken grip cable to be related to the customer reported complaint.For clarification, the instrument was found to have a broken grip cable at the distal end.The broken cable segment that contains the crimp was not returned with the instrument.The root cause of this failure is attributed to a component failure.Additional observation not reported by site that is related to the primary failure: this instruments grip tips were not moving intuitively, i.E.They were not following the mtm input commands smoothly.This failure was caused by the broken grip cable.The root cause of this failure is attributed to component failure.Additional observations not reported by site that are not related to the primary failure: the instrument was found to have a broken pivot pin at the distal end.The root cause of this failure is attributed to mishandling/misuse.The instrument was found to have a firing failure during in-house testing.The instrument was placed on an in-house system.The instrument failed the firing test at the start of the firing sequence.The root cause is not determinable.

• Brand Name: ENDOWRIST
• Common Device Name: STAPLER 45
• 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: 17015752
• Report Number: 2955842-2023-14879
• Device Sequence Number: 12506386
• Product Code: NAY
• UDI-Device Identifier: 00886874112427
• UDI-Public: (01)00886874112427(10)T10190205
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K140553
• 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): 05/31/2022

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: 470298-12
• Device Catalogue Number: 470298
• Device Lot Number: T10190205 0095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/31/2022
• Initial Report FDA Received Date: 05/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2019
• 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 Sex: Unknown