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	Foreign Body In Patient (2687)
Date of Event	04/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event is being reported because it was reported that a fragment was retained in the patient after the instrument tip broke and fell into the patient.The instrument usage was reviewed by an isi clinical development engineer (cde).The cde confirmed that cadiere forceps instruments were not designed to be used with a third party instrument such as the ultrasound probe.A review of the instrument log for the cadiere forceps instrument (part number: 420049-13, lot number: n10201214-160) associated with this event has been performed.Per logs, the instrument was last used on (b)(6) 2021 on system (b)(4).The instrument was used for 25 minutes and 39 seconds.The instrument had 3 lives remaining out of 10 max tool uses.A review of the video of this event was performed by an isi cde and the following information was provided: "besides being misuse to use the cadiere with the ultrasound probe, the surgeon was also not holding the instrument flush with the fin of the probe, which would impart additional forces to the grips and may lead to the damage observed." this event is being reported as an adverse event because it was reported that a fragment that broke off of the cadiere forceps instrument was retained in the patient.The root cause of the instrument breakage leading to the fragment fall has been identified as user error.
Event or Problem Description
It was initially reported that the cadiere forceps instrument was used to guide an ultrasound probe during the procedure, and one of the instrument tips broke off and fell into the patient.The instrument tip was reported to have been retained in the patient.Follow-up: on 05/07/2021, intuitive surgical inc.(isi) contacted the customer and additional information was obtained about the complaint: the cadiere forceps instrument broke when it was grasping an ultrasound probe to assist in guiding it to obtain a view of the tumor.The surgeon searched for the fragment in the bowel, but could not find it.The surgeon said that retaining this fragment was equal to a patient retaining a clip on their artery and there was no harm.An x-ray was performed after the procedure was completed during the same day; the fragment could not be found in the x-ray.It was unknown if the surgeon had an opinion on how the instrument broke or for how long the instrument was in use for before it broke.It was reported there was no patient injury during this procedure.It was reported that the patient was discharged and has not returned to the hospital.The procedure was a small intestine segmental resection.A procedure video was provided for review.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the cadiere forceps instrument involved with this complaint and completed the device evaluation.Failure analysis confirmed the reported event.The instrument was found to have a broken grip at the grip base.A piece approximately 0.65" x 0.20" was found to be broken off the wrist assembly and the broken piece was not returned with the instrument.This failure is most commonly caused by mishandling/misuse, such as excess force applied to the instrument jaws.
Additional Manufacturer Narrative
Based on a re-evaluation of the complaint information, this complaint has been reclassified as an adverse event and product problem rather than just a adverse event, as previously reported.Corrected information can be found the following field: b1.B1 updated from "adverse event" to "adverse event and product problem".
Event or Problem Description
Refer to h10/h11 for follow-up information.

• 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: david wang ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 11891918
• Report Number: 2955842-2021-10566
• Device Sequence Number: 16490815
• Product Code: NAY
• UDI-Device Identifier: 00886874111338
• UDI-Public: (01)00886874111338(10)N10201214
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/29/2021

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: N10201214 160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2021
• Initial Date Received by Manufacturer: 04/29/2021
• Supplement Date Received by Manufacturer: 06/30/2021; 04/29/2021
• Initial Report FDA Received Date: 05/27/2021
• Supplement Report FDA Received Date: 07/26/2021; 05/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2020
• 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: Unknown