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

Model Number	420207-10
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Isi has requested the tenaculum forceps instrument involved with this complaint be returned but it has not been received yet.Therefore, the root cause of the alleged customer reported failure mode has not been determined.A follow-up mdr will be submitted upon completion of the failure analysis evaluation and if additional information is received.No image or video was available for review.A review of the instrument log for the tenaculum forceps instrument (part number 420207-10| lot/serial number (b)(4) associated with this event has been performed.Per this review of the logs, the tenaculum forceps instrument was last used in a procedure on (b)(6) 2022 via system serial# (b)(4).The alleged instrument had 8 uses remaining after this last usage.This complaint is reportable malfunction event due to the following conclusion: it was alleged that the tenaculum forceps instrument moved with unintuitive motion.Unintuitive motion could lead to subsequent tissue damage.While there was no harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.
Event or Problem Description
It was reported that during a da vinci-assisted myomectomy surgical procedure, the tenaculum forceps instrument was recognized on arm 3; however, the instrument wrist moved in the opposite way from the surgeon's commands.A backup instrument of same kind was used to continue the procedure.The procedure was completed with no report of patient injury.An intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the tenaculum forceps instrument was inspected prior to use with no abnormality.The unintuitive motion occurred once persistently so the customer replaced with a new instrument.The drape that the instrument was attached to was not returned.There was no patient injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the tenaculum forceps instrument involved with this complaint and completed the device evaluation.Failure analysis investigations replicated and confirmed the customer reported complaint "the wrist part of the jaw moves in the other way apart from the console." failure analysis found the primary failure of failed intuitive motion be related to the customer reported complaint.This instrument¿s grip tips were not moving intuitively, i.E.They were not following the master tool manipulator (mtm) input commands smoothly.The instrument grips exhibited unintuitive motion.The probable root cause of the unintuitive motion could not be determined.
Event or Problem Description
Refer to h10/h11 for follow-up information.

• Brand Name: ENDOWRIST
• Common Device Name: TENACULUM FORCEPS
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 15884352
• Report Number: 2955842-2022-15620
• Device Sequence Number: 5250242
• Product Code: NAY
• UDI-Device Identifier: 00886874111659
• UDI-Public: (01)00886874111659(10)N10201130
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K050369
• 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): 10/31/2022

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: 420207-10
• Device Catalogue Number: 420207
• Device Lot Number: N10201130 719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/31/2022
• Supplement Date Received by Manufacturer: 12/13/2022
• Initial Report FDA Received Date: 11/30/2022
• Supplement Report FDA Received Date: 01/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2020
• 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: Female