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

Model Number	478055-03
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event investigation is in progress.A review of an image of the instrument, provided by the customer, shows the heat shrink tubing has become separated/torn from the main tube.The detached segment of shrink tubing is attached via rubber band to the main tube.
Event or Problem Description
It was reported that during a da vinci-assisted cholecystectomy procedure, the cadiere forceps instrument was observed to be skewed to one side and would not move.The customer tried to pull it out from the port, but it would not come out.While trying to force the cadiere forceps instrument out, the outer cover of the instrument detached and tore off.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the port incision did not need to be increased in size to remove the instrument.No functionality issue with the instrument was noted during the case.Upon final removal of the cadiere forceps instrument, the instrument's wrist was straightened, but there was resistance upon removal.The surgical staff did not notice any damage to the cannula after the event occurred.The fragment was retrieved during the same procedure, and it was visually confirmed that no fragments were left behind.No additional procedure was required to remove the fragment.No post-operative tests like an x-ray or ultrasound were performed due to the issue; the procedure was completed robotically with a backup instrument.The patient has not returned to the hospital due to experiencing any post-surgical complications related to retaining a foreign object.The instrument is not available for return.
Event or Problem Description
Refer to h11 for follow-up information.
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.Failure analysis found the instrument to have damaged insulation on the outer main tube.The tube insulation was damaged at the bottom of the instrument near the distal end.The damage was on the distal end of the instrument and the damage insulation was returned with the instrument, but fragments could be on missing insulation.

• 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: 21208630
• Report Number: 2955842-2024-24089
• Device Sequence Number: 20872248
• Product Code: NAY
• UDI-Device Identifier: 00886874113608
• UDI-Public: (01)00886874113608(10)N10171024
• 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): 12/26/2024

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: 478055-03
• Device Catalogue Number: 478055
• Device Lot Number: N10171024 0005
• 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: 12/26/2024
• Supplement Date Received by Manufacturer: 03/11/2025
• Initial Report FDA Received Date: 01/22/2025
• Supplement Report FDA Received Date: 04/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2017
• 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: Unknown