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	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The mega suture cut needle driver instrument involved with this complaint has not been returned for evaluation.Therefore, failure analysis of the product related to the complaint cannot be performed.Site history review: a review of the site's complaint history does not show any additional complaints related to this product and/or this event.Image/video review: no image or video clip for the reported event was submitted for review.Product and event verification: a review of the instrument log for the mega suture cut needle driver instrument (part number: 470309-14, lot number: t10200109-0049) associated with this event has been performed.Per logs, the instrument was last used on (b)(6) 2020 on system sk1671.The alleged event occurred on the last use of the instrument.The surgeon used a backup instrument.This complaint is reportable due to the following: the mega suture cut needle driver instrument is designed to grab and manipulate needles to enable suturing during a da vinci assisted surgical procedure.It was reported that during a da vinci-assisted surgical procedure, one of the jaws from the mega suture cut needle driver instrument broke, and fell inside the patient.The broken jaw was retrieved during the same procedure.The procedure was completed with injury to the patient.All fragments were retrieved and no additional surgical intervention was required.However, unintended fragment(s) falling into the patient may require surgical intervention.At this time, it is unknown what caused the breakage to occur.The product is not implantable.
Event or Problem Description
It was reported that during a da vinci-assisted inguinal hernia repair surgical procedure, one of the jaws from the mega suture cut needle driver instrument broke and fell inside the patient.The broken jaw was retrieved during the same procedure.The procedure was completed with no injury to the patient.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained additional information: the instrument was not inspected prior to use.The instrument was on its last use.The surgeon was suturing when the instrument¿s jaw fell inside the patient.Before the jaw was broken off, the instrument functioned normally and there was no instrument collision during the procedure.The surgeon used a backup instrument and continued with the procedure.The hospital could not provide any patient related information due to hippa policy.
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 due to the report of a fragment falling into the patient.Intuitive surgical, inc.(isi) received the instrument involved with this complaint and completed the device evaluation.Failure analysis investigation confirmed/replicated the reported complaint.The instrument was found to have a broken grip-tip at the grip base.A piece approximately 0.11" x 0.33" was found to be broken off and was not returned.The root cause of this failure is attributed to the user.Corrected information can be found the following fields: updated section b1 to be adverse event and product problem updated section b2 to be required intervention updated section h1 to add serious injury updated d4 to include udi number d9 updated per receipt of device.
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: 10841051
• Report Number: 2955842-2020-11200
• Device Sequence Number: 4135320
• Product Code: NAY
• UDI-Device Identifier: 00886874112434
• UDI-Public: (01)00886874112434(10)T10200109
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2020

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: T10200109 0049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/21/2020
• Supplement Date Received by Manufacturer: 10/21/2020
• Initial Report FDA Received Date: 11/14/2020
• Supplement Report FDA Received Date: 06/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2020
• 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