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

Model Number	470309-14
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci- assisted malignant hysterectomy surgical procedure, the tip of the mega suturecut needle driver instrument could no longer be opened and closed.It was reportedly unknown if a fragment from the instrument had fallen inside the patient.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the instrument was in use for about 30 minutes prior to the issue.The procedure was completed robotically with no report of patient injury.No other information was available.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the mega suturecut needle driver instrument involved with this complaint and completed the device evaluation.Failure analysis investigations confirmed the customer reported complaint "the tip can no longer be opened and closed." failure analysis found the primary failure of mechanical indentations/ burrs to be related to the customer reported complaint.The instrument was found to have blade damage.Both blade edges were indented, which prevents the blades from closing.The root cause of mechanical indentations/burrs instrument blades is typically attributed to user mishandling/misuse.A review of the instrument log for the mega suturecut needle driver instrument (part# 470309-14| lot/serial# (b)(4)) associated with this event has been performed.Per this review of the logs, the instrument was last used on (b)(6) 2022.No image or procedure video was provided for review.This complaint is being reported based on the following conclusion: it was alleged that a fragment from the mega suturecut needle driver instrument possibly fell inside the patient during a da vinci assisted procedure.Failure analysis confirmed the instrument had blade damage.The issue was 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.Follow-up was attempted, but the patient information was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.The product is not implantable.

• 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: 15263474
• Report Number: 2955842-2022-13577
• Device Sequence Number: 6013363
• Product Code: NAY
• UDI-Device Identifier: 00886874112434
• UDI-Public: (01)00886874112434(10)N11200320
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K131861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/21/2022

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: N11200320 0381
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/21/2022
• Initial Report FDA Received Date: 08/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2020
• 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: Female