MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; LONG TIP FORCEPS

Model Number	470048-08
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the long tip forceps instrument to perform failure analysis.The long tip forceps instrument was analyzed and found to exhibit unintuitive motion.The instrument was installed on an in-house system and driven.The motion exhibited by the instrument was precise, and proportional to what was commanded by the master tool manipulators; however, the tip moved in the opposite direction.Motion issues can be caused by something else in the backend (ex: broke cable, loose cable, broken input, cracked input, cracked clamping pulley, loose clamping pulley screw, binding of gears, other).No damage to the back-end components on the instrument were found.
Event or Problem Description
It was reported that prior to the start of a da vinci-assisted surgical procedure, the tip on the long tip forceps instrument would not articulate correctly.The procedure was completed with no reported injury.

• Brand Name: ENDOWRIST
• Common Device Name: LONG TIP 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: 20550998
• Report Number: 2955842-2024-21213
• Device Sequence Number: 3162987
• Product Code: NAY
• UDI-Device Identifier: 00886874112243
• UDI-Public: (01)00886874112243(10)S11150526
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K131861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/02/2024

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: 470048-08
• Device Catalogue Number: 470048
• Device Lot Number: S11150526 0001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/02/2024
• Initial Report FDA Received Date: 10/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2015
• 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: Prefer Not To Disclose