MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; MEGASUTURECUT ND

Model Number	420309-05
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/13/2018
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 could not confirm the customer reported failure.The instrument was placed on an in-house system and the instrument passed recognition and engagement tests.However, the instrument was found to have a broken pitch cable at the clevis hub.The broken cable segment that contains the crimp was still installed in the clevis.Isi has conducted a device history record (dhr) review for this device and did not find any non-conformances that were related to this reported event.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 prior to the start of a da vinci-assisted total benign hysterectomy procedure, the mega suture cut instrument could not be recognized by the system.There was no report of fragment(s) falling inside the patient, patient harm, adverse outcome or injury.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: MEGASUTURECUT ND
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale
• MDR Report Key: 7574997
• Report Number: 2955842-2018-10263
• Device Sequence Number: 274944
• Product Code: NAY
• UDI-Device Identifier: 00886874111796
• UDI-Public: (01)00886874111796(10)N10171115
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 05/21/2018

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: 420309-05
• Device Lot Number: N10171115 630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2018
• Initial Report FDA Received Date: 06/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1