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

Model Number	420178-08
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/23/2019
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 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.One of the blade edges was indented, which prevented the blades from closing.This failure is most commonly caused by mishandling/misuse.
Event or Problem Description
During a da vinci assisted myomectomy procedure, it was reported that the curved scissors had a broken cable.The procedure was completed and there was no patient injury.

• Brand Name: ENDOWRIST
• Common Device Name: CURVED SCISSORS
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• MDR Report Key: 9508934
• Report Number: 2955842-2019-10988
• Device Sequence Number: 16286781
• Product Code: NAY
• UDI-Device Identifier: 00886874111499
• UDI-Public: (01)00886874111499(10)N10170929
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 12/10/2019

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: 420178-08
• Device Lot Number: N10170929123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/10/2019
• Initial Report FDA Received Date: 12/23/2019
• 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.