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

Model Number	471190-04
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2022
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 (fa) found the primary failure of broken grip tip to be related to the customer reported complaint.The instrument was found to have a broken grip at the distal tip.A piece approximately 0.051" x 0.018" was found to be broken off.The broken piece was not returned.Common causes of the failure mode broken instrument grips-tips are typically attributed to the user mishandling/misuse, such as excess force applied to the instrument jaws.This damage during use may result from applying excess force on the instrument shafts and/or tips during handling, insertion, usage (overloading), or removal.This complaint is considered a reportable event due to the following conclusion: failure analysis acknowledged that a fragment was missing from a portion of the device that enters the patient (distal end).Based on the information provided, there was no report from the customer that a fragment from the instrument fell into the patient during the procedure.At this time, it is unknown what caused the instrument grip tip breakage to occur.While there was no report of harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur, as unintended broken fragment(s) falling inside the patient may require surgical intervention.
Event or Problem Description
It was reported that during a da vinci-assisted radical extraperitoneal without lymphadenectomy prostatectomy surgical procedure, the cobra grasper instrument had insufficient grip/grip failure (jaws not working).A back-up instrument of the same kind was used, and the procedure was completed with no reported injury or delay.Intuitive surgical, inc.(isi) has reached out to the reporter to obtain additional patient/event information but has not yet received a response as of the date of this report.

• Brand Name: ENDOWRIST
• Common Device Name: COBRA GRASPER
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 16101158
• Report Number: 2955842-2022-16270
• Device Sequence Number: 17699210
• Product Code: NAY
• UDI-Device Identifier: 00886874121481
• UDI-Public: (01)00886874121481(10)K10220321
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K214095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/06/2022

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: 471190-04
• Device Catalogue Number: 471190
• Device Lot Number: K10220321 0046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/06/2022
• Initial Report FDA Received Date: 01/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 74 KG