MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SINGLE-SITE; CADIERE FORCEPS

Model Number	478055-04
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The cadiere forceps instrument was analyzed and found to have a broken distal clevis at the base of the clevis.The broken piece was returned, measuring roughly 0.3620¿ x 0.2355¿ in size.The clevis did not show abrasions or scratches on the outer surface.Components adjacent to the broken clevis did not show damage which may indicate potential mishandling.The instrument was also found to have a broken grip at the grip base.A piece approximately 24.57mm x 6.26mm was found to be broken off.The broken piece was returned with the instrument.The complaint was confirmed by failure analysis.The probable root cause is attributed to damage during use, which may result from applying excess force on the instrument tip during handling, insertion, usage (overloading), or removal.Instrument collisions with other hand-held instrumentation or instrument driven outside the field of view can also cause damage to the instrument distal clevis.
Event or Problem Description
Refer to h11 for follow-up information.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the tip of the cadiere forceps instrument broke off and fell inside the patient.The fragment was retrieved during the same procedure.The instrument was removed and replaced with a backup.Following this, the user continued and completed the procedure robotically with no further issues.No known impact or patient consequence was reported.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained additional information: all fragments were retrieved, which was confirmed visually.The issue occurred during dissecting.No post-operative tests were performed to check for remaining fragments.There was no patient injury.There was no report of post-surgical complications, and the patient has not returned to the hospital.The surgeon was unsure of what caused the instrument/accessory to break or caused the fragment falling issue.The instrument did not collide with any other instruments or other hard material during the surgical procedure.The fragments did not fall inside the patient during an instrument tip/accessory collision.The instrument was not removed during the procedure (prior to the breakage).The surgical staff did not feel any resistance upon removal of the instrument through the cannula.Upon final removal of the instrument, the instrument's wrist was straightened.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has received the cadiere forceps instrument for failure analysis evaluation.However, as of the date of this report, the evaluation of the instrument has not been completed.A review of an image provided of the instrument is consistent with the alleged complaint.It appears that the distal end of the instrument is broken and separated entirely from the instrument.The root cause of the failure mode cannot be confirmed without the returned device.

• Brand Name: SINGLE-SITE
• Common Device Name: CADIERE FORCEPS
• 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: 20668845
• Report Number: 2955842-2024-21502
• Device Sequence Number: 20675481
• Product Code: NAY
• UDI-Device Identifier: 00886874113608
• UDI-Public: (01)00886874113608(11)240530(10)K10240530
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K152448
• 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): 10/17/2024

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: 478055-04
• Device Catalogue Number: 478055
• Device Lot Number: K10240530 0017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/17/2024
• Supplement Date Received by Manufacturer: 12/31/2024
• Initial Report FDA Received Date: 11/12/2024
• Supplement Report FDA Received Date: 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2024
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Prefer Not To Disclose