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	01/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An rma has been issued to the customer requesting to have the instrument returned; however, isi has not yet received the cadiere forceps instrument for evaluation.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if additional information is obtained.The batch sequence number of the instrument's lot number was not provided.Therefore, an instrument log review of the product related to the complaint cannot be performed at this time.There was no photo or video provided by the site for review.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.This complaint is being reported due to the following: it was alleged that a fragment of a broken instrument fell inside the patient and was retrieved during the same procedure.At this time, is unknown what caused the instrument breakage.Although there was no patient injury reported, if the issue were to recur, it could cause or contribute to an adverse event.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the cadiere forceps instrument jaw was broken and fell inside the patient.The fragment was retrieved during the same procedure.The procedure was completed with no reported injury.Intuitive surgical (is) followed up with the initial reporter and obtained the following additional information: the fragment was retrieved using a laparoscopic instrument.The surgeon believes that excessive force might have caused that instrument to break.The instrument was in use for about 90 minutes prior to breakage.The instrument was inspected prior to the procedure and no anomalies were noted.No issue was noticed with the functionality of the instrument during the procedure and the instrument did not collide with other instruments.The surgical staff did not feel resistance upon removal of the instrument through the cannula.No damage was noticed to the cannula or the instrument by the surgical staff upon final removal.There was no adverse effect or injury to the patient.The patient has not returned to the hospital due to experiencing any post-surgical complications related to retaining a foreign object.Photographic images of the device or video recording of the procedure are not available for review.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the cadiere forceps instrument involved with this complaint and completed the device evaluation.Failure analysis investigation confirmed the customer reported complaint.The instrument was found to have a broken grip at the grip base.A piece approximately 0.210" x 0.674" was found to be broken off the yaw pulley.The broken piece was returned.The root cause of broken instrument grips-tips is typically attributed to the instrument mishandling, such as excess force applied to the instrument jaws.A review of the device logs for the cadiere forceps (part# 420049-13 | (b)(6) ) associated with this event has been performed.Per this review of the logs, the cadiere forceps was last used on 12-jan2021 via system (b)(6).There were 4 uses remaining after this last usage.
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 product problem, as previously reported.
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: 11330712
• Report Number: 2955842-2021-10139
• Device Sequence Number: 1115462
• Product Code: NAY
• UDI-Device Identifier: 00886874111338
• UDI-Public: (01)00886874111338(10)N10200317
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K050369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/19/2021

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: N10200317 003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2021
• Initial Date Received by Manufacturer: 01/19/2021
• Supplement Date Received by Manufacturer: 03/19/2021; 01/19/2021
• Initial Report FDA Received Date: 02/15/2021
• Supplement Report FDA Received Date: 04/14/2021; 05/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2020
• 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