MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SINGLE-SITE; CLIP APPLIER, MEDIUM-LARGE

Model Number	478053-04
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The instrument was analyzed and found to have grip input disk #6 completely detached.Other backend components adjacent to the broken inputs did not show damage.The complaint was confirmed by failure analysis.
Event or Problem Description
It was reported that during a da vinci-assisted cholecystectomy surgical procedure, the medium-large clip applier instrument fired the first clip and it would not close.There was a loud crunch sound heard and the instrument was removed.The user completed the procedure with no further issue reported.No known impact or patient consequence was reported.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the issue occurred while the surgeon attempted to clamp on a vessel or tissue bundle.When the instrument was inserted via guided tool change (gtc), the surgeon went to fire the clip, but the instrument did not close, and a very loud crunching sound was heard.The instrument would rotate but would not close or fire.The weck hem-o-lok medium-large clips were used with the instrument.The vessel or tissue bundle was not greater than the specified diameter suggested in the user manual.The issue was resolved by using a new clip applier instrument.

• Brand Name: SINGLE-SITE
• Common Device Name: CLIP APPLIER, MEDIUM-LARGE
• 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: 20929505
• Report Number: 2955842-2024-23197
• Device Sequence Number: 14775777
• Product Code: NAY
• UDI-Device Identifier: 00886874113585
• UDI-Public: (01)00886874113585(11)230907(10)K10230907
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K152448
• 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): 11/18/2024

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: 478053-04
• Device Catalogue Number: 478053
• Device Lot Number: K10230907 0003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2024
• Initial Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2023
• 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 Age: 28 YR
• Patient Sex: Male