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

Model Number	471190-04
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, a broken jaw was noted croken grasper.The procedure was completed with no reported injury to the patient.Evaluation of the returned device found a piece of the grip base broken off.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the customer reported that everything was filled out on the complaint form and there was no further information to give.There was no significant damage or harm.
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 found to have a broken grip at the grip base of grip.A piece approximately 0.210" x 0.678" was found to be broken off.The broken piece was not returned.The complaint was confirmed by failure analysis, which indicates that the device may have contributed to the customer reported issue.

• 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: 17923131
• Report Number: 2955842-2023-19141
• Device Sequence Number: 2983253
• Product Code: NAY
• UDI-Device Identifier: 00886874121481
• UDI-Public: (01)00886874121481(10)N10201207
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 09/13/2023

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: N10201207 0118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/13/2023
• Initial Report FDA Received Date: 10/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2020
• 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