MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; GRASPING RETRACTOR

Model Number	420278-09
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	10/21/2020
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 replicated/confirmed the customer reported complaint.Failure analysis found the primary failure of broken/loose cable to be related to 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 missing from the clevis.Root cause of this failure is attributed to a component failure.A site history was performed and no related complaints were found.A review of system logs showed that the instrument was last used on system number (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 grasping retractor 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 grasping retractor instrument had broken strings.The procedure was completed and there was no patient injury.Intuitive surgical, inc.(isi) made multiple follow-up attempts to obtain additional information.However, no further details have been received as of the date of this report.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: GRASPING RETRACTOR
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• MDR Report Key: 11145017
• Report Number: 2955842-2021-10017
• Device Sequence Number: 19005077
• Product Code: NAY
• UDI-Device Identifier: 00886874111772
• UDI-Public: (01)00886874111772(10)N10190826
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/16/2020

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: 420278-09
• Device Catalogue Number: 420278
• Device Lot Number: N10190826 862
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/16/2020
• Initial Report FDA Received Date: 01/11/2021
• 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