MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; MEGA SUTURECUT ND

Model Number	470309-14
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	04/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the claim against the product by the customer noting, broken.An investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The instrument was analyzed and failure analysis investigations confirmed, the customer reported complaint.Failure analysis found, the primary failure of broken grip to be related to the customer reported complaint.The instrument was found to have a broken grip at the grip base.A piece approximately 0.119 x 0.340 was found to be broken off.The broken piece was returned.Common causes of the failure mode broken instrument grip-tips are typically attributed to mishandling/misuse; such as excessive force applied to the instrument jaws.This damage during use may result from applying excess force on the instrument shafts and/or tips during handling, insertion, usage (overloading), or removal.This failure is typically attributed to mishandling/misuse.
Event or Problem Description
It was reported, that the mega suturecut needle driver instrument was broken/loose.There was no report of patient involvement.

• Brand Name: ENDOWRIST
• Common Device Name: MEGA SUTURECUT ND
• 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: 16926730
• Report Number: 2955842-2023-13258
• Device Sequence Number: 6920890
• Product Code: NAY
• UDI-Device Identifier: 00886874112434
• UDI-Public: (01)00886874112434(10)N10190301
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K131861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/17/2023

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: 470309-14
• Device Catalogue Number: 470309
• Device Lot Number: N10190301 0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/06/2023
• Initial Report FDA Received Date: 05/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2019
• 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