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

Model Number	420327-04
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the medium-large clip applier would not apply the clip.The clip fell from inside the patient's anatomy and was retrieved during the same procedure.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the robotic coordinator and obtained the following additional information: the customer reported that the instrument was inspected prior to use.At the time, the surgeon did not observe any issues with the medium-large clip applier instrument.No collisions were observed.It was confirmed the clip was retrieved during the same procedure with no additional procedures required.When the instrument was removed, the wrist was straightened and no resistance was noticed.There was no damage observed on the instrument after the reported issue.Post-operative tests like x-rays and ultra sounds were not performed.A backup clip applier instrument was used to continue and the procedure was completed robotically with no reported injury or harm.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the medium-large clip applier instrument involved with this complaint and completed the device evaluation.Failure analysis could not replicate nor confirm the reported complaint.The medium-large clip applier instrument was found to have the grips damaged and therefore, the clip test could not be performed.It was noted that both grips were bent.This failure is typically attributed to mishandling/misuse.

• 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: 16925199
• Report Number: 2955842-2023-13122
• Device Sequence Number: 6921817
• Product Code: NAY
• UDI-Device Identifier: 00886874111826
• UDI-Public: (01)00886874111826(10)N10180305
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K050369
• 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): 09/24/2020

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: 420327-04
• Device Catalogue Number: 420327
• Device Lot Number: N10180305 265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/24/2020
• Initial Report FDA Received Date: 05/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2018
• 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