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

Model Number	470309-14
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) had not yet received the mega suture needle driver instrument for evaluation.Therefore, the root cause of the customer reported failure mode could not be determined.A follow up mdr will be submitted for additional information received.A review of the instrument log for the product associated with this event shows that the mega suture needle driver instrument (part# 470309-14 lot# n10190515-0050) was last used on 09/04/2019 on system# sk2117.There is no indication that the instrument was used in subsequent procedures after the alleged event reported on this record.A review of the site's complaint history does not show any additional complaints related to this product.A log review was conducted, which resulted in the following findings: it was confirmed the mega suture cut needle driver instrument part# 470309-14 lot# n10190515-0050 was last used on 09/04/2019 during a paraoesophageal hernia repair on system sk2117 for 0:51:00 minutes.The logs show the customer replaced the instrument with mega suture cut needle driver part# 470309-14 lot# n10190529-0023.It was noted the mega suture cut needle driver instrument part# 470309-14 lot# n10190515-0050 had 4 lives remaining.A review of the site's complaint history does not show any additional complaints related to this product.This complaint is being reported due to the following conclusion: during a da vinci-assisted surgical procedure, a mega suture needle driver instrument broke and fragments fell inside the patient.While there was no report of any patient harm, adverse outcome or injury, at this time it is unknown what caused the breakage to occur.A follow-up mdr will be submitted if the instrument is returned or if additional information is received.Follow-up was attempted, but the patient information was either unknown, unavailable, or not provided.Device expiration date was left blank as this instrument has 10 usages allotted to it, which are tracked by the da vinci surgical system.This reported issue occurred on the instrument's 6th usage and, therefore, had not expired.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the suture needle driver instrument broke during use.It was noted there were broken parts in the patient and the doctor cleared out all the broken parts before the patient left the operating room (or).The original intended procedure was to suture the patient after surgery.There was no reported injury or harm.On 06/17/2020, intuitive surgical, inc.(isi) received user facility report (b)(4) stating: "suture needle driver broken during use.Broken parts in patient.Dr.Cleared out all broken parts before patient left or.Original intended procedure was to suture patient after surgery." intuitive surgical, inc.(isi) made multiple follow-up attempts to obtain additional information.However, no further details have been received as of the date of this report.
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.Corrected information can be found the following field: b1, b2, and h1: b1 updated from "product problem" to "adverse event and product problem".B2 updated to "required intervention".H1 updated from "malfunction" to "serious injury".
Event or Problem Description
Refer to h10/h11 for follow-up information.

• Brand Name: ENDOWRIST
• Common Device Name: MEGA SUTURECUT ND
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: david wang ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 10274589
• Report Number: 2955842-2020-10645
• Device Sequence Number: 2233990
• Product Code: NAY
• UDI-Device Identifier: 00886874112434
• UDI-Public: (01)00886874112434(10)N10190515
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2020

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: 470309-14
• Device Catalogue Number: 470309
• Device Lot Number: N10190515 0050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/17/2020
• Supplement Date Received by Manufacturer: 06/17/2020
• Initial Report FDA Received Date: 07/15/2020
• Supplement Report FDA Received Date: 05/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Sex: Unknown