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

Model Number	478055-04
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the da vinci product to perform failure analysis.The cardiere forceps instrument was analyzed and found to have insulation damage on the outer main tube.The tube insulation damage measured roughly 5.200" x 2.980".The damage was on the distal end of the instrument.The missing fragments were not returned.The complaint regarding the detached instrument housing was confirmed by failure analysis.
Event or Problem Description
It was reported that during a da vinci-assisted cholecystectomy surgical procedure, the cadiere forceps functioned properly.However, the adapter detached from the housing when attempting to remove the instrument.The customer tried to pull out the instrument but it was stuck.The customer reinserted the instrument causing the sheath of the shaft to tear and become lodged at the end of the cannula.The customer was able to remove the instrument.The user completed the procedure using a backup cadiere forceps with no further issue reported.No fragment fell inside the patient.Isi followed up with the initial reporter and obtained the following additional information: the instrument was removed with the cannula but there was no increase in port size to remove the instrument and cannula together.The instrument was not grasping tissue when the issue occurred.An irk was not used to remove the instrument.There was no instrument collision and no injury to the patient.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
The cadiere forceps instrument was re-evaluated by intuitive surgical inc.(isi) quality engineering (qe) for root cause determination.Following information was obtained: the probable root cause is attributed to damage during use, which may result from an accidental drop of the instrument, inadvertent collisions with other instruments or hard surfaces, improper cleaning during reprocessing, an excessive contact with abrasive or hard surfaces during transport, reprocessing, or tip cover installation/removal.This issue can be resolved by using an alternate instrument to complete the procedure.

• 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: 20779920
• Report Number: 2955842-2024-22443
• Device Sequence Number: 9032601
• Product Code: NAY
• UDI-Device Identifier: 00886874113608
• UDI-Public: (01)00886874113608(11)240327(10)K10240327
• 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): 11/24/2025

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: 478055-04
• Device Catalogue Number: 478055
• Device Lot Number: K10240327 0001
• 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): Follow-Up
• Initial Date Received by Manufacturer: 11/07/2024
• Supplement Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 11/26/2024
• Supplement Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2024
• 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
• Patient Sex: Unknown