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

Model Number	470309-14
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the instrument involved with this complaint and completed the device evaluation.Failure analysis investigations confirmed the customer reported complaint.The mega suturecut needle 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.The instrument was also found to have blade damage.Both blade edges were indented, which prevents the blades from closing.This failure is most commonly caused by mishandling/misuse.A review of the site's complaint history does not show any additional complaints related to this product.System logs showed that the instrument was last used on system number (b)(4) on (b)(6) 2020 and it had 1 life remaining.Based on the information provided at this time, this complaint is being reported because the mega suturecut needle 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.Although there was no reported patient injury, if the failure were to recur, it could cause or contribute to an adverse event.
Event or Problem Description
It was reported that prior to a da vinci assisted procedure, the mega suturecut needle had a broken wire.The procedure was completed and there was no patient injury.Intuitive surgical, inc.(isi) followed up with the initial reporter in an attempt to obtain additional information.However, the reporter stated that she had provided al the information while returning the instrument.

• Brand Name: ENDOWRIST
• Common Device Name: MEGA SUTURECUT ND
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• MDR Report Key: 10452800
• Report Number: 2955842-2020-10794
• Device Sequence Number: 19801501
• Product Code: NAY
• UDI-Device Identifier: 00886874112434
• UDI-Public: (01)00886874112434(10)N10180622
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/31/2020

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: 470309-14
• Device Catalogue Number: 470309
• Device Lot Number: N10180622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/31/2020
• Initial Report FDA Received Date: 08/26/2020
• 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