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

Model Number	420318-05
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	10/14/2020
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.The small grasping retractor 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.This failure is most commonly caused by component failure.Product and event verification: a review of instrument logs confirmed that the small grasping retractor was last used on system# rsh0035 on (b)(6) 2020 and it had 8 uses remaining.Site history review: a review of the site's complaint history does not show any additional complaints related to this product and/or this event.Image/video review: 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 classified as a reportable malfunction event due to the following conclusion: the small 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 surgeon stated that the small grasping retractor instrument was not working correctly.They noticed wires sticking out from the instrument.The instrument was immediately removed with no injury to the patient.The procedure was completed and there was no patient injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained patient-related information, but no other details related to the event.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: SMALL GRASPING RETRACTOR
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• MDR Report Key: 10896303
• Report Number: 2955842-2020-11256
• Device Sequence Number: 16895504
• Product Code: NAY
• UDI-Device Identifier: 00886874111802
• UDI-Public: (01)00886874111802(10)N10190404
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/30/2020

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: 420318-05
• Device Catalogue Number: 420318
• Device Lot Number: N10190404 365
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2020
• Initial Report FDA Received Date: 11/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 63