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

Model Number	420230-10
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/08/2021
Type of Reportable Event	Serious Injury
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 when closing of the grips was attempted.The movement was described as ¿uncontrolled.¿ it was noted that the patient sustained bleeding from the inferior mesenteric artery (ima), but it was not severe.The volume of blood loss was reported to be less than 750 ml and the patient was not transfused with blood.The procedure was completed with the da vinci surgical system.On (b)(6) 2021, intuitive surgical, inc.(isi) received the following additional information from the surgeon via a nurse at the site: there was no bleeding in the patient for the procedure and no loose cable seen on the instrument.According to the surgeon, there was uncontrolled movement during application of the clip when closing the jaws.There was no loose cable seen in the instrument during application of the clip.The surgeon checked that the clip was properly latched on after application of the clip.The procedure was completed robotically, and the procedure was not prolonged due to the issue.There was no fragment that fell into the patient as well as no bleeding that occurred in the patient.
Additional Manufacturer Narrative
Based on the information provided, the cause of the reported complication cannot be determined as there are contradictory statements regarding the occurrence of bleeding.The instrument was received, and isi performed a device evaluation.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.A clip test was performed, and the instrument passed.The instrument was fully functional.A review of the logs found no failures recorded that were related to the reported complaint.There was no problem detected.No cables were found loose or broken on the distal or proximal end of the instrument.A video clip was provided from this reported procedure and evaluated by an isi clinical development engineer (cde).The investigation indicated that while the video quality was poor, there was unexpected yaw motion during the second clip application.No bleeding was observed.This complaint is being reported due to the following conclusion: during a da vinci-assisted low anterior resection procedure, it was alleged that there was a non-intuitive motion issue with the large clip applier instrument and that bleeding occurred from the ima.While the bleeding was noted to not be severe, did not require a blood transfusion, and is not currently connected to the report of non-intuitive motion, the reported failure mode could likely cause or contribute to an injury if it were to recur.The cause of the operative complication is unknown.It is also unclear what medical intervention, if any, was administered due to the intra-operative complication.Blank mdr fields: follow-up was attempted, but the missing patient information was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.Field is blank because the product is not implantable.Information for the blank fields is not available.Fields are not applicable.

• 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: 14541361
• Report Number: 2955842-2022-11911
• Device Sequence Number: 12446718
• Product Code: NAY
• UDI-Device Identifier: 00886874111680
• UDI-Public: (01)00886874111680(10)N10190408
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 420230-10
• Device Catalogue Number: 420230
• Device Lot Number: N10190408 844
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/23/2021
• Initial Report FDA Received Date: 05/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2019
• 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 Age: 73 YR
• Patient Sex: Female
• Patient Weight: 76 KG