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

Model Number	471190-04
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	04/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the cobra grasper instrument associated with this complaint and completed its investigation.The failure analysis (fa) investigations confirmed the customer reported complaint.The cobra grasper instrument was found to have a broken grip at the grip base.Fa found the primary failure of a broken grip to be related to the customer reported complaint.A piece approximately 0.71" x 0.20" was found to be broken off the wrist assembly and the broken piece was not returned.The root cause is attributed to mishandling/misuse, such as excess force applied to the instrument jaws.A review of the instrument log for the cobra grasper (part number 471190-04/ lot number n10210208 0009) associated with this event has been performed.Per logs, the cobra grasper instrument was last used in a procedure on (b)(6) 2022 via system (b)(4).The alleged instrument had 14 uses remaining after the last procedural use.An event verification confirmed the procedure was performed on the reported event date (b)(6) 2022 on system (b)(4).No image or video of the procedure was provided for review.This complaint is considered a reportable malfunction event due to the following conclusion: failure analysis acknowledges 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.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.
Event or Problem Description
It was reported that during central processing, the cobra grasper instrument was missing the other tip.There was no report of patient involvement.The cobra grasper is a multiple-use endoscopic instrument with a grasping tip to be used in conjunction with the da vinci system.The instrument is designed to grab, manipulate, retract, and dissect tissue during a da vinci assisted surgical procedure.

• 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: 14726583
• Report Number: 2955842-2022-12206
• Device Sequence Number: 19389743
• Product Code: NAY
• UDI-Device Identifier: 00886874121481
• UDI-Public: (01)00886874121481(10)N10210208
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/17/2022

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: N10210208 0009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 06/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2021
• 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 Sex: Female