MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI; CANNULA SEAL

Model Number	470361-08
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has requested for return of the cannula seal accessory for failure analysis evaluation.As of the date of this report, the instrument has not been returned.Therefore, the cause of the failure mode cannot be determine.
Event or Problem Description
It was reported that during a da vinci-assisted unilateral inguinal hernia procedure, the cannula seal accessory ripped while the customer was inserting mesh inside the patient with a grasper instrument.During insertion of the grasper, the customer saw a blue fragment/piece inside the patient.The cannula seal was inspected, and it was noted to be torn.It is unknown if there was an instrument/accessory collision.The instrument wrist was straightened during removal.The fragment was retrieved using a back-up instrument during the same procedure which was completed robotically.There are no photographic images available.

• Brand Name: DA VINCI
• Common Device Name: CANNULA SEAL
• 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: 18545477
• Report Number: 2955842-2024-10318
• Device Sequence Number: 15684786
• Product Code: GCJ
• UDI-Device Identifier: 10886874112547
• UDI-Public: (01)10886874112547(10)L80230921
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K133845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 470361-08
• Device Catalogue Number: 470361
• Device Lot Number: L80230921
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/22/2023
• Initial Report FDA Received Date: 01/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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: 61 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White