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

Model Number	470309-15
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	01/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the mega suturecut needle driver involved with this complaint and completed the device evaluation.Failure analysis investigation confirmed the reported failure.Failure analysis (fa) found the instrument had a broken grip at the grip base.A piece approximately 0.12" x 0.22" was found to be broken off the distal end.The broken piece was not returned.The root cause of this failure is attributed to user mishandling/misuse.
Event or Problem Description
It was reported that during central processing, a broken tip of mega suture cut needle driver was reported.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: 16883425
• Report Number: 2955842-2023-12757
• Device Sequence Number: 14908500
• Product Code: NAY
• UDI-Device Identifier: 00886874112434
• UDI-Public: (01)00886874112434(10)N10200211
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/03/2021

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: 470309-15
• Device Catalogue Number: 470309
• Device Lot Number: N10200211 0180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2021
• Initial Report FDA Received Date: 05/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2020
• 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 Sex: Unknown