MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; ROUND TIP SCISSORS

Model Number	470007-05
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the instrument involved with this complaint and completed the device evaluation.The 8mm round tip scissors has been returned and evaluated by the failure analysis team.Failure analysis investigations replicated/confirmed the customer reported complaint "cable broke." the instrument was found to have a broken pitch cable at the distal end.The broken cable segment that contains the crimp was still installed in the clevis.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.No investigation required as no image or video clip for the reported event was submitted for review.A review of system logs for system (b)(4) with a procedure date of (b)(6) 2020, confirmed a round tip scissors instrument (pn# 470007-05 / lot # t10191114-0046) was used during this procedure.The instrument has maximum 10 uses.There were 8 more uses remaining.Based on the failure analysis investigations, this complaint is being classified 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 the patient, the reported failure mode could cause or contribute to an adverse event if it were to recur.
Event or Problem Description
It was reported that during a da vinci-assisted myomectomy surgical procedure, the 8mm round tip scissors instrument cable broke during surgery.The procedure was completed with no reported injury.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.

• Brand Name: ENDOWRIST
• Common Device Name: ROUND TIP SCISSORS
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• MDR Report Key: 10776457
• Report Number: 2955842-2020-11159
• Device Sequence Number: 11047450
• Product Code: NAY
• UDI-Device Identifier: 00886874112168
• UDI-Public: (01)00886874112168(10)T10191114
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K150284
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/09/2020

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: 470007-05
• Device Catalogue Number: 470007
• Device Lot Number: T10191114 0046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/09/2020
• Initial Report FDA Received Date: 11/03/2020
• 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