MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; 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	05/23/2018
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 confirmed the customer reported failure.The instrument was found to have a broken pitch cable at the distal clevis hub.As a result, intuitive motion at the wrist was no longer being experienced.The broken cable segment that contains the crimp was still installed in the clevis.A device history record (dhr) review for this device was conducted and did not find any non-conformances that would affect any material of the final product and/or the quality or performance of the instrument.The customer reported complaint does not itself constitute an mdr reportable event; however, the broken pitch cable found during failure analysis could cause or contribute to an adverse event if the malfunction were to recur.
Event or Problem Description
It was reported that during a da vinci-assisted hysterectomy procedure, the mega needle driver instrument was not moving intuitively.The surgeon then noted a broken "steel wire" and replaced the instrument to complete the procedure.There was no report of fragments falling inside the patient, patient harm, adverse outcome or injury.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: MEGA NEEDLE DRIVER
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale
• MDR Report Key: 7673617
• Report Number: 2955842-2018-10359
• Device Sequence Number: 10974847
• Product Code: NAY
• UDI-Device Identifier: 00886874111611
• UDI-Public: (01)00886874111611(10)N10161017
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K050369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2018

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 Lot Number: N10161017 814
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/19/2018
• Initial Date Received by Manufacturer: 06/26/2018
• Supplement Date Received by Manufacturer: 06/26/2018
• Initial Report FDA Received Date: 07/10/2018
• Supplement Report FDA Received Date: 07/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES; DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Age: 53 YR