MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; LARGE HEM-O-LOK CLIP APPLIER

Model Number	420230-11
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the claim against the product by the customer noting clip application failure, an investigation is in progress to determine the cause of this reported event.The large hem-o-lok clip applier instrument has not yet been returned to isi for evaluation.Therefore, the root cause of the customer reported failure mode cannot yet be determined.A follow-up mdr will be submitted if the instrument is returned (post engineering evaluation) or if additional information is received.Additional information is being gathered to determine the contribution of the device to the customer reported issue.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the large hem-o-lok clip applier instrument had a poor clip closure.The procedure was completed with a delay of less than 15 minutes and no patient injury.Intuitive surgical, inc.(isi) contacted the site and obtained the following additional information regarding this event: the surgeon could not apply the clip when the instrument was in the patient.No further details were provided.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The large hem-o-lok clip applier instrument was analyzed, which did not replicate or confirm the customer reported event.The instrument was placed and driven on an in-house system.The instrument passed the recognition and engagement tests.The instrument moved intuitively with full range of motion in all directions.The grips opened and closed properly.The clip test was performed twice and passed.The instrument was fully functional.No product issue was identified.Also, the instrument was visually inspected and evaluated for its mechanical characteristics.The failure analysis investigations and in-house testing of the returned instrument revealed no issues related to the customer reported issue.
Event or Problem Description
Refer to h10/h11 for follow-up information.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: LARGE HEM-O-LOK CLIP APPLIER
• 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: 17195935
• Report Number: 2955842-2023-16583
• Device Sequence Number: 20667152
• Product Code: NAY
• UDI-Device Identifier: 00886874111680
• UDI-Public: (01)00886874111680(10)N10210802
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K050369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2023

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: 420230-11
• Device Catalogue Number: 420230
• Device Lot Number: N10210802 882
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/25/2023
• Supplement Date Received by Manufacturer: 07/11/2023
• Initial Report FDA Received Date: 06/24/2023
• Supplement Report FDA Received Date: 08/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2021
• 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: 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