MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; MEGA SUTURECUT ND

Model Number	470309-14
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during central processing, a tip had fallen off on one side of the mega suturecut needle driver.There was no report of patient involvement.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the customer confirmed that the issue was identified during the central processing.The procedure prior was completed as planned.The customer was not sure if the instrument was used during the case, or if another was used in its place.The details of the procedure are unknown.To the customer's knowledge, there was no report of fragments falling into the patient.The instrument cleaning or sterilization process has not been changed.There were no photo images or video recordings available for isi review.
Additional Manufacturer Narrative
Based on the claim against the product by the customer noting a broken jaw, an investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The mega suturecut needle driver instrument was analyzed and found to have the carbide insert detached from one the grips.The brazing material, approximately 0.11" x 0.093" in size was not returned with the instrument.This failure is most commonly caused by a supplier quality process.Common causes of the failure mod carbide insert damage on instrument grips -tips are typically attributed to mishandling/misuse.The complaint regarding a broken jaw was confirmed by failure analysis, which indicates that the device did contribute to the customer reported issue.The probable root cause of bent/broken tips is attributed to damage to the carbide insert during use, which may result from applying excess force on the instrument grip tips during handling, insertion, usage (overloading), or removal.This complaint is being submitted as a reportable event due to the following conclusion: failure analysis confirmed the instrument breakage that could result in a fragment fall inside the patient, which was attributed to a mod carbide insert damage on instrument grips -tips and typically attributed to mishandling/misuse.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 as unintended fragment(s) falling into the patient may require surgical intervention.

• Brand Name: ENDOWRIST
• Common Device Name: MEGA SUTURECUT ND
• 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: 16570102
• Report Number: 2955842-2023-11382
• Device Sequence Number: 5703952
• Product Code: NAY
• UDI-Device Identifier: 00886874112434
• UDI-Public: (01)00886874112434(10)N10190524
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/21/2023

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: 470309-14
• Device Catalogue Number: 470309
• Device Lot Number: N10190524 0014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/21/2023
• Initial Report FDA Received Date: 03/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2019
• 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 Sex: Unknown