MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; MEGA NEEDLE DRIVER

Model Number	420194-10
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/26/2020
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 needle driver 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.The mega needle driver was last used on system# (b)(4) on (b)(6) 2020 and it had 8 lives remaining.No image or video was provided for review.Based on the information provided at this time, this complaint is being classified as a reportable malfunction event due to the following conclusion: the mega needle driver 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 no patient harm was reported, if the issue were to recur, it could potentially result in an adverse event.
Event or Problem Description
It was reported that during a da vinci assisted procedure, the wires of the mega needle driver broke intra-abdominally.The surgeon was aware of the issue and the instrument was removed safely.The instrument was noted to have 8 remaining lives.The procedure was completed with a backup da vinci instrument of the same kind and there was no patient injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the reporter stated that the patient was a (b)(6) year old hispanic female weighing (b)(6) kg.On the day of the procedure, the patient underwent complete blood cell (cbc) type and screen, and covid tests.The patient had a history of arthritis, hypertension and stress incontinence.

• Brand Name: ENDOWRIST
• Common Device Name: MEGA NEEDLE DRIVER
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• MDR Report Key: 10411577
• Report Number: 2955842-2020-10750
• Device Sequence Number: 3177830
• Product Code: NAY
• UDI-Device Identifier: 00886874111611
• UDI-Public: (01)00886874111611(10)N10180323
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K050369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/21/2020

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: 420194-10
• Device Catalogue Number: 420194
• Device Lot Number: N10180323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/21/2020
• Initial Report FDA Received Date: 08/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 87