MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SINGLE-SITE; FUNDUS GRASPER

Model Number	478058-04
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Open or Close (2921)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	02/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the current information provided, the cause of the intra-operative complication cannot be determined.The product was returned to intuitive surgical, inc (isi) for evaluation, and no functional issue was found.A follow-up mdr will be submitted if additional information is obtained.Isi received the fundus grasper instrument associated with this complaint, and a failure analysis (fa) investigation was completed.The fa team did not replicate nor confirm the customer reported complaint.The instrument was placed and driven on an in-house system, where it passed the recognition and engagements tests and moved intuitively.The grips opened and closed properly, and the instrument was found to be fully functional.No product issue was identified.A review of the logs revealed the following error code: 256 | emergency stop button was pressed by a user on the psc.A probable root cause could not be determined, as no problem was detected.Issues related to instrument errors or user reported complications with no underlying product issue may be related to customer-induced problems, including mishandling/misuse and recognition issues.A field service engineer (fse) was dispatched to the site, and the site confirmed that there had been no further issues.The system test drive was successful.The fse made an electrical/mechanical adjustment to correct the reported problem, and the system was tested and verified as ready for use.This complaint is considered a reportable event due to the following conclusion: the fundus grasper instrument was stuck on the fundus of the gallbladder, and the jaws would not open, despite attempting to use two instrument release kits to release the jaws from the tissue.The surgeon cut the tissue around the instrument to remove it from the patient.Although the affected tissue would have been removed regardless of this issue, this malfunction could cause or contribute to a more serious adverse event were it to recur.
Event or Problem Description
It was reported that during a davinci-assisted cholecystectomy surgical procedure, the fundus grasper jaws would not release from the gallbladder.The emergency stop button was pressed, and the site attempted to remove the instrument via the instrument release kit.The kit did not successfully open the instrument's jaws, and a second kit was used, also unsuccessfully.The surgeon decided to cut the tissue around the instrument to remove it from the patient and then continue the procedure with one universal surgical manipulator (usm).The site contacted a technical support engineer (tse) at the time of the event, and after guiding the staff through the use of the release kit the second time and informing them that rebooting the system would not resolve the problem, the tse advised the staff that the surgeon "would have to determine the best way to proceed." the instrument was installed on usm 3.The procedure was completed, with no other reported injury.Intuitive surgical, inc.(isi) contacted the surgeon for the procedure, and the following additional information was obtained: the surgeon stated that the instrument was grasping the top of the fundus at the time of the event, and he "took the cystic duct and artery already." the assistant was grasping the very top of the fundus through the assistant port.The jaws would not release; the staff said they were turning the release key, and it wouldn't click.They tried another release kit, and the same thing happened.The staff could not pull the instrument off of the arm; they checked to see if a drape was caught, but they couldn't find an issue anywhere.The da vinci technical support team advised them that the release key was the only troubleshooting option available.Since it was the end of the case, the surgeon decided to cut the instrument out.He used the scissors to cut the section of the fundus out that was stuck, and then once he cut it free, he "used the hook and scissors to take the edge off of the liver." he could not remember if he used another grasper for this last bit of the surgery, but he thought he might not have needed another instrument on the arm.He had been using the fundus grasper up until that point, "and it was fine." he thought there might have been a fault on that arm earlier in the case that was cleared by the staff, but he could not remember.There was no unexpected bleeding, and the patient was fine.The patient did not have post-operative complications, and no long-term complications are expected.The patient was discharged.

• Brand Name: SINGLE-SITE
• Common Device Name: FUNDUS GRASPER
• 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: 16572187
• Report Number: 2955842-2023-11387
• Device Sequence Number: 15248840
• Product Code: GCJ
• UDI-Device Identifier: 00886874113622
• UDI-Public: (01)00886874113622(10)K10220605
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K152448
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/21/2023

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: 478058-04
• Device Catalogue Number: 478058
• Device Lot Number: K10220605 0020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/21/2023
• Initial Report FDA Received Date: 03/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2022
• 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 Age: 37 YR
• Patient Sex: Male
• Patient Weight: 109 KG
• Patient Ethnicity: Hispanic