MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; VESSEL SEALER

Model Number	410322-05
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The vessel sealer was analyzed and found to have stuck grips.The instrument was placed on an in-house system and passed the recognition and engagement tests.The grips did not open and close properly during manual articulation and could not be tested on the system due to instrument failing self-test.The instrument was not fully functional.Further investigation confirmed additional observations.The instrument was placed on the in-house system and failed self-test during initialization.The instrument was visually inspected and found there was no blade exposure observed due to the stuck grips.No initialization failures were reported in the logs.No physical damage was observed.The instrument failed the recognition based on log review.Error code 31009 was observed during log review, but the instrument was recognized on the in-house system.The complaint was confirmed by failure analysis, which indicates that the device may have contributed to the customer reported issue.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.Information for the blank fields in section e1 is not available.Fields g5 and g7 are not applicable.
Event or Problem Description
It was reported that during a da vinci-assisted distal gastrectomy surgical procedure, the tips of the vessel sealer were not opening or closing while the instrument was installed onto the universal surgical manipulator (usm).The customer noted that the reported event continued to occur when the vessel sealer was removed manually.The procedure was completing as planned with no reported injury.Intuitive surgical, inc.(isi) followed up with the customer and obtained the following additional information: it was unknown if the vessel sealer extend (vse) worked at all during this procedure.It was unknown if the jaws were stuck on tissue when the issue occurred.Also, it was unknown if there was any adverse effect to grasped tissue.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: VESSEL SEALER
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 20044924
• Report Number: 2955842-2024-18329
• Device Sequence Number: 7959453
• Product Code: NAY
• UDI-Device Identifier: 10886874111113
• UDI-Public: (01)10886874111113(10)M10230509
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K110639
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/26/2024

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: 410322-05
• Device Catalogue Number: 410322
• Device Lot Number: 244
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/26/2024
• Initial Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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: Prefer Not To Disclose