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	08/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the mega suture cut needle driver instrument involved with this complaint and completed the device evaluation.Failure analysis (fa) concluded that the reported failure was confirmed/replicated; "end has slipped off and is lodged on the side of the shaft." the instrument was found to have the main tube broken.No material was found missing.This failure is most commonly caused by mishandling/misuse.
Event or Problem Description
It was reported that after a da vinci-assisted surgical procedure, end of a mega suture cut needle driver instrument had slipped off and was lodged on the side of the instrument shaft.The procedure was completed with no reported injury.On (b)(6) 2020, intuitive surgical, inc.(isi) obtained the following additional information regarding the reported event: after a da vinci-assisted surgical procedure, it was observed that the tip/end of a mega suture cut needle driver instrument had slipped and had become lodged on the side of the shaft.There was no report of fragment fall into the patient or any other additional piece slipping.It was unknown if the instrument was even used during this procedure.The procedure completed robotically with no reported injury.

• 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: 16883427
• Report Number: 2955842-2023-12755
• Device Sequence Number: 5822195
• Product Code: NAY
• UDI-Device Identifier: 00886874112434
• UDI-Public: (01)00886874112434(10)N11190701
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/10/2020

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: N11190701 0224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/10/2020
• Initial Report FDA Received Date: 05/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2019
• 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