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	09/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The cobra grasper instrument was analyzed and the reported failure was confirmed.The instrument was found to have the main tube broken.A piece measuring approximately 0.180¿ x 0.144¿ was not returned with the instrument.The complaint was confirmed by failure analysis, which indicates that the device may have contributed to the customer reported issue.
Event or Problem Description
It was reported that during central processing, the cobra grasper instrument had physical damage to the metal connector at the tip.No known impact or patient consequence was reported.Evaluation found the instrument had the main tube broken.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
• 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: 18000160
• Report Number: 2955842-2023-19579
• Device Sequence Number: 7537784
• Product Code: NAY
• UDI-Device Identifier: 00886874121481
• UDI-Public: (01)00886874121481(10)K10230420
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/04/2023

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: K10230420 0009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/20/2023
• 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: Unknown