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

Model Number	471190-04
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to the start of a da vinci-assisted simple prostatectomy surgical procedure, the cobra grasper was missing half of the jaw.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the issue was identified when the instrument packaging was opened.The instrument was not used on the patient.The missing half of the jaws was not located and will not be returned with the instrument.A new instrument was opened for use in the procedure.
Additional Manufacturer Narrative
Intuitive has received the cobra grasper associated with this complaint and completed investigations.Failure analysis investigations confirmed the customer reported complaint of the instrument missing one half of the jaw.The instrument was found to have a broken grip at the grip base.A piece approximately 0.65" x 0.20" was found to be broken off the wrist assembly.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 logs showed that the cobra grasper was last used on (b)(6) 2022 in a simple prostatectomy procedure performed on system (b)(4).This complaint is considered a reportable event due to the following conclusion: the customer acknowledged that a fragment was missing from a portion of the device that enters the patient (distal end).The report was confirmed through failure analysis.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: 15222718
• Report Number: 2955842-2022-13456
• Device Sequence Number: 17595281
• Product Code: NAY
• UDI-Device Identifier: 00886874121481
• UDI-Public: (01)00886874121481(10)K10211206
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 07/15/2022

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: K10211206 0035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/15/2022
• Initial Report FDA Received Date: 08/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2021
• 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: Unknown
• 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: Male