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

Model Number	471190-04
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to starting a da vinci-assisted cholecystectomy surgical procedure, the cobra grasper instrument had half of the forceps missing.The procedure was completed with no reported injury.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.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the customer confirmed that the patient was not in the room when the issue was identified.There is no further information available.
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 ¿half of forceps missing from cobra grasper¿.Failure analysis found the primary failure of broken grip tips to be related to the customer reported complaint.The instrument was found to have a broken grip at the grip base.A piece approximately 0.21" x 0.6 was found to be broken off the yaw pulley.The broken piece was not returned.The root cause of broken instrument grips -tips is typically attribute to the mishandling/misuse, such as excess force applied to the instrument jaws.No image or video clip for the reported event was submitted for review.A review of the device logs for the cobra grasper (part#471190-04| lot/serial#(b)(4)) associated with this event has been performed.Per this review of the logs, the cobra grasper was last used on (b)(6) 2022 during a cholecystectomy procedure on system serial#(b)(4).There were 13 uses remaining after this last usage.The instrument has max 18 lives.This complaint is being reported due to the following conclusion: it was reported that prior to starting a da vinci-assisted surgical procedure, the cobra grasper had half of the forceps missing.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.

• 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: 15195562
• Report Number: 2955842-2022-13378
• Device Sequence Number: 14838236
• Product Code: NAY
• UDI-Device Identifier: 00886874121481
• UDI-Public: (01)00886874121481(10)N10210823
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 07/12/2022

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: N10210823 0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/12/2022
• Initial Report FDA Received Date: 08/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2021
• 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 Age: 46 YR
• Patient Sex: Male
• Patient Weight: 113 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American