MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SINGLE-SITE; CROCODILE GRASPER

Model Number	478059-04
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) performed failure analysis and found the crocodile grasper instrument to have the plastic proximal clevis broken causing the grip set to be dislodged.As a result of the breakage, there was a piece missing approximately 0.198¿ x 0.339¿.The root cause of the broken proximal clevis is attributed to mishandling/misuse/excessive force.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, a fragment from a crocodile grasper instrument broke off inside the patient when the surgeon grasping with the instrument.The fragment was retrieved in the same procedure by a the backup crocodile grasper instrument, the event was not caused by an instrument collision and the procedure was completed as planned.Intuitive surgical, inc.Made multiple unsuccessful attempts to obtain additional information.

• Brand Name: SINGLE-SITE
• Common Device Name: CROCODILE 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: 16928120
• Report Number: 2955842-2023-13538
• Device Sequence Number: 6921377
• Product Code: NAY
• UDI-Device Identifier: 00886874113639
• UDI-Public: (01)00886874113639(10)N10190527
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K152448
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/13/2021

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: 478059-04
• Device Catalogue Number: 478059
• Device Lot Number: N10190527 0015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/13/2021
• Initial Report FDA Received Date: 05/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2019
• 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