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

Model Number	420309-03
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An rma was issued to evaluate the intuitive surgical, inc.(isi) device.Additional information is being gathered to determine the contribution of the device to the customer-reported issue.Review of the provided image was performed by isi regulatory post market surveillance specialist (rpms) and obtained the following additional information: the provided image was consistent with the reported failure of the mega suturecut needle driver instrument wire broke and the tip fell off into the patient.The root cause of the failure mode cannot be confirmed without the returned device.Blank mdr fields: the missing patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.The expiration date for section d4 is not applicable.Field d6 is blank because the product is not implantable.Fields g5 and g7 are not applicable.
Event or Problem Description
It was reported that during a da vinci-assisted pancreatoduodenectomy surgical procedure, the mega suturecut needle driver instrument wire broke and the tip fell off into the patient.The fragment was retrieved in the same procedure.The customer used a spare instrument to proceed.The procedure was completed.Intuitive surgical, inc (isi) followed up with the initial reporter and obtained the following additional information: the mega suturecut needle driver instrument was inspected prior to use with no damage found.The reported issue occurred while the patient was being stitched.The surgeon believed what caused the fragment to fall into the patient is the quality of the product.The procedure was in use 10 minutes prior to the occurrence of the problem.The surgeon did not encounter any functional problems with the instrument during the surgical procedure.The instrument was in a contact with other instruments or hard material but there was no collision.A fragment fell into the patient, and the instrument was removed during the procedure.The instrument wrist was straightened prior to removal.The surgical staff did not feel any resistance upon removal through the cannula.All fragments were confirmed to be retrieved through vision.The patient had an x-ray performed to check for remaining fragments.The procedure was completed robotically.There was no injury to the patient, and the patient has not returned to the hospital due to experiencing any post-surgical complications related to retaining a foreign object.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received a da vinci product to perform failure analysis.The mega suturecut needle driver instrument was analyzed and found to have a broken grip at the grip base.A piece approximately 0.138" x 0.316" was found to be broken off.The broken piece was returned.No damaged or broken cables were found.The complaint was confirmed by failure analysis.
Event or Problem Description
Refer to h10/h11 for follow-up information.

• Brand Name: ENDOWRIST
• Common Device Name: MEGASUTURECUT 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: 18015829
• Report Number: 2955842-2023-19640
• Device Sequence Number: 7582040
• Product Code: NAY
• UDI-Device Identifier: 00886874111796
• UDI-Public: (01)00886874111796(10)N10141204
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K050369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 420309-03
• Device Catalogue Number: 420309
• Device Lot Number: N10141204 822
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/28/2023
• Supplement Date Received by Manufacturer: 01/05/2024
• Initial Report FDA Received Date: 10/26/2023
• Supplement Report FDA Received Date: 01/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2014
• 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