MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENTRYGUIDE; KIT, C.6.6.6 (STANDARD)

Model Number	430022-10
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	04/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the entry guide involved with this issue and performed failure analysis testing.The entry guide was found to be broken at the weld, between the lumen shaft and entry guide frame.Visual inspection was performed and there were no obvious signs of physical damage.No missing material was observed.
Event or Problem Description
It was reported that prior to the start of a da vinci-assisted cholecystectomy surgical procedure, the entry guide kit was separated and could not be used.A backup kit was used to continue the procedure.There was no report of fragment(s) falling inside the patient.The procedure was completed with no report of patient injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the instrument was inspected prior to use with no abnormality.The issue was identified prior to port placement.The customer confirmed that no fragment fell inside of the patient.There was no patient injury/harm.Photographic images of the device(s) or a video recording of the procedure were not available for isi review.
Additional Manufacturer Narrative
The entry guide kit has been further investigated and tested by the failure analysis engineer (advanced failure analysis).The entry guide was broken at the weld and does not appear to be missing any pieces.A visual inspection did not find any obvious physical damage to the exterior of the accessory.There were no signs of impact or excessive force applied to the accessory, including cracks, dents, or abrasions.Inspection of the weld site appeared to show a portion where the accessory was not fully welded, which could lead to the two pieces of the entry guide to separate.

• Brand Name: ENTRYGUIDE
• Common Device Name: KIT, C.6.6.6 (STANDARD)
• 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: 17000802
• Report Number: 2955842-2023-14562
• Device Sequence Number: 16739403
• Product Code: NAY
• UDI-Device Identifier: 10886874113506
• UDI-Public: (01)10886874113506(10)K10221229
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K182371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2023

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: 430022-10
• Device Catalogue Number: 430022
• Device Lot Number: K10221229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/25/2023
• Supplement Date Received by Manufacturer: 07/06/2023
• Initial Report FDA Received Date: 05/25/2023
• Supplement Report FDA Received Date: 08/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/29/2022
• 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: 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