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

Model Number	420230-08
Medical Device Problem Codes	Unintended System Motion (1430); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the large clip applier instrument involved with this complaint and completed device evaluation.Failure analysis (fa) neither replicated nor confirmed the customer reported complaint.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 and were able to hold and snap the clip during the clip test.The instrument was fully functional and no problem was detected during the device evaluation.A review of the system and instrument logs for the procedure date of (b)(6) 2021 has been performed.There were no observed events in the system logs that would suggest a product issue and logged events are in line with normal system functionality.No image or video clip for the reported event was submitted for review.This complaint is being reported due to the following conclusion: it was alleged that the large clip applier instrument presented a non-intuitive motion issue during a surgical procedure.At this time, it is unknown what caused the non-intuitive motion event to occur.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.
Event or Problem Description
It was reported that during a da vinci -assisted low anterior resection procedure, there was a non-intuitive motion issue with the large clip applier instrument.The procedure was completed without reported patient harm, injury, or adverse outcome.Follow-up was performed with the surgeon, and additional information was obtained.There was non-intuitive motion while applying the clip with the large clip applier.It was unknown whether the clip was properly latched on after application of the clip, but it was noted that the surgeons were experienced and well versed on how to use the instrument.The surgeons were also not sure that the bleeding occurred due to the non-intuitive motion of the large clip applier.There was no loose cable seen during application of the clip.There was no bleeding or injury to the patient.

• 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: 14520005
• Report Number: 2955842-2022-11819
• Device Sequence Number: 6634656
• Product Code: NAY
• UDI-Device Identifier: 00886874111680
• UDI-Public: (01)00886874111680(10)N10170704
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K050369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/23/2021

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: 420230-08
• Device Catalogue Number: 420230
• Device Lot Number: N10170704 195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/23/2021
• Initial Report FDA Received Date: 05/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2017
• 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