MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; COBRA GRASPER

Model Number	470190-04
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the cobra grasper instrument involved with this complaint and completed the device evaluation.Failure analysis confirmed the reported complaint.The instrument was found to have a broken pitch cable at the distal clevis hub.The broken cable segment that contains the crimp was missing from the clevis.The root cause of the broken pitch cable is attributed to a component failure.A review of the instrument log for the cobra grasper instrument was performed.Per the logs, the device was not used on the reported event date of (b)(6) 2020 which indicates the issue was identified prior to use.The instrument was last used on (b)(6) 2020 on system (b)(4).The cobra grasper had 4 uses remaining after the last use.A review of the site's complaint history does not show any additional complaints related to this product.No image or video clip for the reported event was submitted for review.Based on the information provided at this time, this complaint is being reported because this 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.While there was no patient harm or injury, the reported failure mode identified during failure analysis could potentially cause or contribute to an adverse event if it were to recur.
Event or Problem Description
It was reported that during central processing, a broken cable was noted.There was no report of patient involvement.

• Brand Name: ENDOWRIST
• Common Device Name: COBRA GRASPER
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• MDR Report Key: 11214441
• Report Number: 2955842-2021-10075
• Device Sequence Number: 3795310
• Product Code: NAY
• UDI-Device Identifier: 00886874112335
• UDI-Public: (01)00886874112335(10)N10200302
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K150284
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/11/2021

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: 470190-04
• Device Catalogue Number: 470190
• Device Lot Number: N10200302 0053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/11/2021
• Initial Report FDA Received Date: 01/22/2021
• 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