MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; CADIERE FORCEPS

Model Number	420049-13
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the cadiere forceps instrument involved with this complaint and completed the device evaluation.Failure analysis replicated and confirmed the reported complaint.For clarification, the cadiere forceps instrument was found to have broken grips on both sides at the grip base.The broken grips measured approximately 0.210¿ x 0.675¿.The broken pieces were returned.The root cause of this failure is most commonly attributed to mishandling/misuse.A remotefe/ tableau log review was conducted, which resulted in the following findings: the logs show the customer used cadiere forceps instrument part# 420049-13 lot# n12190404-048 on (b)(6) 2021 with system rsh0035 and had 0 lives remaining.This last usage of the device per the log review matches the reported event date, indicating that the instrument was not used after the date of the reported event.
Event or Problem Description
It was reported that during a da vinci-assisted cholecystectomy surgical procedure, the customer noted the cadiere forceps instrument jaw broke off when hitting another instrument and fell into the patient.The surgeon removed the fragment from the patient.It was noted that the fragment was retrieved using a backup instrument.The intuitive representative made sure the fragment removed matched up to the instrument to confirm nothing was left behind.The instrument wrist was straightened upon removal.The fragment was available for return.No video/image was available for review.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the clinical territory associate (cta) who created this complaint and obtained the following additional information: the cta informed the cadiere forceps instrument was in use for about in on hour prior to the reported fragment falling into the patient.It was noted the instrument was inspected prior to use with no damage observed.The cta informed the cadiere forceps instrument was removed at least once prior to the fragment falling.When the reported fragment fell into the patient, the cta informed the cadiere forceps instrument was inactive when another instrument that was being maneuvered hit the idle instrument and broke the tip.A backup instrument was used to retrieve the broken fragment.A visual confirmation on behalf of the cta and circulating nurse was performed, and confirmed both pieces fit together.No additional surgical procedures, x-rays, or ultra sounds were performed.The surgeon believed that it was due to his excessive for that the instrument broke.It was noted the cadiere forceps instrument had no functionality issues while in use.Upon final removal of the instrument, the wrist was straightened and no additional damage was observed to the instrument nor the cannula.The cta confirmed the cannula was examined with a gauge pin and no issues were observed.A backup davinci instrument was used to continue the case.The cta informed the cadiere instrument would be returning with the fragment.No video/image was available for review.The procedure was completed with no reported injury or harm.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: CADIERE 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: 16928186
• Report Number: 2955842-2023-13600
• Device Sequence Number: 6756448
• Product Code: NAY
• UDI-Device Identifier: 00886874111338
• UDI-Public: (01)00886874111338(10)N12190404
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K050369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/08/2021

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: 420049-13
• Device Catalogue Number: 420049
• Device Lot Number: N12190404 048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/08/2021
• Initial Report FDA Received Date: 05/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2019
• 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 Age: 65 YR
• Patient Sex: Male