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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the site's complaint history does not show any additional complaints related to this product and/or this event.No image or video clip of the reported event was submitted for review.A review of instrument logs was performed.Per the review, the device was not used on the reported event date of (b)(6) 2021.The instrument was last used on (b)(6) 2021 on system (b)(4).This supports the allegation that the instrument was not used on a patient on the date that the issue was identified.The mega suturecut needle driver had 1 use remaining after last use.Intuitive surgical, inc.(isi) received the mega suturecut needle driver associated with this complaint and completed its investigation.Failure analysis (fa) confirmed the reported issue that the instrument cable "popped." the instrument was found to have a broken pitch cable at the distal end and the broken cable segment that contains the crimp was missing from the clevis.The mega suturecut needle driver instrument is designed to grab and manipulate needles to enable suturing during a da vinci assisted surgical procedure.Based on the additional information obtained from failure analysis investigation, this complaint is being assessed as a reportable event due to the following conclusion: this instrument is designed with two pitch cables each with a crimp at the distal end.If a pitch cable breaks at the distal end, a cable segment and/or the crimp could fall into the patient.While there was no harm or injury to a patient, the reported failure mode is reportable since the observed failure mode of a broken pitch cable could cause or contribute to an adverse event if it were to recur.
Event or Problem Description
It was reported that during central processing, the instrument cable "popped".There was no report of patient involvement.Intuitive surgical inc.(isi) completed customer follow-up and obtained the following information: the instrument was inspected prior to use and there was no damage identified.The customer confirmed there were no fragments that fell inside the patient during last usage.Patient information was requested, but was unavailable.Also, the operating room staff confirmed that the instrument was never used/inserted into the surgical field.The broken instrument was identified outside of the procedure and processed for return.

• Brand Name: ENDOWRIST
• Common Device Name: MEGA SUTURECUT ND
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• MDR Report Key: 11427684
• Report Number: 2955842-2021-10207
• Device Sequence Number: 2776000
• Product Code: NAY
• UDI-Device Identifier: 00886874112434
• UDI-Public: (01)00886874112434(10)N10200511
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K131861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/10/2021

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: N10200511 0211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2021
• Initial Report FDA Received Date: 03/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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