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

Model Number	420327-07
Medical Device Problem Codes	Difficult to Open or Close (2921); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the claim against the product by the customer noting that the medium-large clip applier (mlca) instrument jaw was deformed and could not release the clip properly, an investigation is in progress to determine the cause of this reported event.Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The mlca instrument was analyzed and found to have one grip bent.The damage was found near the top of the clip groove, causing an offset at the tips.As a result, the clip could not be properly loaded on the grips.The root cause of bent-severely instrument grips is attributed to mishandling/misuse such as excess force applied to the instrument jaws.Severely bent grips are attributed to damage during either use or reprocessing, as severe misalignment of grip tips can be due to accidental drops, incorrect instrument tray or sink sizes for reprocessing, or overloading the tips.The complaint regarding deformed grip of the mlca was confirmed by failure analysis, which indicates that the device did contribute to the customer reported issue.This complaint is considered a reportable event due to the following conclusion: failure analysis confirmed bent grip of the clip applier.Deficiencies in clip application may lead to inadequate hemostasis.While there was no harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.Blank mdr fields: follow-up was attempted, but the missing patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.Field d6 is blank because the product is not implantable.Fields g5 and g7 are not applicable.
Event or Problem Description
It was reported that during a da vinci-assisted right hemicolectomy surgical procedure, the customer reported that the medium-large clip applier (mlca) did not release the clip properly after it was fired.The mlca instrument was removed, and the customer found that that the jaw of the instrument was deformed.The procedure was completed with no reported injury.Intuitive surgical inc.(isi) followed up with the initial reporter and obtained the following additional information: the instrument was not inspected prior to use.The customer did not notice the deformation issue before use.The customer was used medium-large hem-o-lok clip.The clip could not be successfully released from the jaws of the clip applier.The issue occurred in the first fire of the clip applier.The tissue was not greater than 10 mm.The customer used a backup mlca instrument to continue with the procedure.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: MEDIUM-LARGE 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: 16765903
• Report Number: 2955842-2023-12048
• Device Sequence Number: 3063764
• Product Code: NAY
• UDI-Device Identifier: 00886874111826
• UDI-Public: (01)00886874111826(10)K10220110
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K050369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/24/2023

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: 420327-07
• Device Catalogue Number: 420327
• Device Lot Number: K10220110 717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/24/2023
• Initial Report FDA Received Date: 04/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2022
• 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