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

Model Number	420278-09
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the grasping retractor instrument involved with this complaint and completed the device evaluation.Failure analysis (fa) confirmed and replicated the reported complaint.Fa found the pitch cable broken at the distal end through a visual inspection of the instrument.The broken cable segment that contains the crimp was missing from the clevis and was not returned with the instrument.The housing was removed from the back end and no damage was found to the pitch clamping pulley or cables.Pitch cable breakage occurs when the tensile load exceeds the ultimate strength of the material.The pitch cable construction is designed to optimize load and fatigue (cycling) characteristics.Variation in customer use conditions, procedure type, patient anatomy, product handling, instrument tip lengths, grip torque, and manufacturing tolerances are a few variables which can influence pitch cable failure.Additional observations(s) not reported by site: the instrument was found to have a derailed pitch cable at the distal end.The cable segment that contains the crimp remained installed in the clevis.The root cause for this failure is attributed to a component failure.A review of the site's complaint history does not show any additional complaints related to this product or event.A review of the instrument log for the product associated with this event shows that the grasping retractor was last used on (b)(6) 2021 on system (b)(4).The instrument has maximum 10 uses.There are 4 more uses remaining on the instrument.No image or video clip for the reported event was submitted for review.A review of the site's system logs for the reported procedure date was conducted.Investigation revealed there were no related system errors to have occurred during the surgical procedure that would have likely caused or contributed to the reported complaint.Based on the additional information obtained from failure analysis investigations, this complaint is being reported due to the following conclusion: 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 harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.
Event or Problem Description
It was reported that during a da vinci-assisted low anterior resection surgical procedure, the grasping retractor instrument had broken cables at the tip.There was no report of a fragment falling inside the patient due to this event.The procedure was completed with no reported 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
• MDR Report Key: 12229660
• Report Number: 2955842-2021-10865
• Device Sequence Number: 1480722
• Product Code: NAY
• UDI-Device Identifier: 00886874111772
• UDI-Public: (01)00886874111772(10)N10190902
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/01/2021

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: 420278-09
• Device Catalogue Number: 420278
• Device Lot Number: N10190902 237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 07/27/2021
• 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