MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SINGLE-SITE; CROCKODILE GRASPER

Model Number	478059-04
Medical Device Problem Codes	Difficult to Remove (1528); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has received the cadiere instrument involved with this complaint to perform failure analysis; however, the evaluation is not yet complete.
Event or Problem Description
It was reported that during a da vinci-assisted general surgical procedure, the cadiere forceps instrument shaft was not about to pull out from the trocar because the cadiere forceps shaft was not smooth.A backup same dv instrument was used for the procedure.The procedure was converted to laparoscopic surgery with no reported injury.Isi followed up with the initial reporter and obtained the following additional information: the nurse stated that the instrument was lifting the liver at that time and the surgeon could not control the movement of the instrument due to the peeled shaft, so dv robot system was undocked and converted to laparoscopic surgery.The conversion did not result in increasing port size incision or adding additional ports.The issue did occur with the surgeon¿s head inside the surgeon console¿s high resolution stereo viewer.The issue occurred while the surgeon was attempting to manipulate instruments from the surgeon console.The failure did not relate to an inability to move the instrument at all.The movements of the surgeon scale were not appropriate for the instrument.The instrument did not move in the intended direction.The timing of instrument movement was not appropriate.There was no shakiness and/or friction experienced/observed.There was no instrument-to-instrument or system arm-to-arm interference.The issue was not persistent.The action taken was to undock the robot and convert it to laparoscopic surgery.The drape is not available for return.There was no patient was no injury.The device was inspected prior to use.There was no damage was observed.It was unknown at approximately what time the issue occur.The patient tolerated the change with no injury.
Additional Manufacturer Narrative
The cadiere forceps instrument was analyzed, and the complaint was confirmed.The main tube insulation (outer surface) was damaged which appeared to be peeling.The damaged surface measured approximately 0.1175" x 0.1615".This prevents the instrument from pulling out of the trocar.Components adjacent to this main tube did not show damage.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: SINGLE-SITE
• Common Device Name: CROCKODILE GRASPER
• 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: 20662160
• Report Number: 2955842-2024-21704
• Device Sequence Number: 18268413
• Product Code: NAY
• UDI-Device Identifier: 00886874113608
• UDI-Public: (01)00886874113608(10)N10211018
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 478059-04
• Device Catalogue Number: 478059
• Device Lot Number: N10211018 0006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2024
• 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: 11/25/2024
• Initial Report FDA Received Date: 11/12/2024
• Supplement Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2021
• 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 Sex: Unknown