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

Model Number	478058-03
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	10/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the fundus grasper instrument involved with this complaint and completed the device evaluation.Failure analysis confirmed and replicated the reported complaint of ¿the fundus grasper fell apart¿.The fundus grasper instrument was found to have the plastic proximal clevis broken causing the grip tip and the grip pin to be dislodged.There were no broken pieces missing.The root cause of the broken instrument proximal clevis is typically attributed to the misuse/mishandling, such as excess force applied to the distal end of the instrument.The instrument had 8 lives remaining.Event verification: a remote/ tableau log review was conducted, which resulted in the following findings: the logs show the customer used the fundus grasper instrument part# 478058-03 lot# n10180321-0001 on 10/07/2021 with system sk0301.The customer then replaced the instrument with fundus grasper instrument part# 478058-03 lot# n10200907-0002.It was noted that fundus grasper instrument lot# n10180321-0001 was last used on (b)(6) 2021 with system sk0301 and had 8 lives remaining.This last usage of the device per the log review matches the reported event date, indicating that the instrument was not used after the date of the reported event.System log review: a review of the site's system logs for the reported procedure date was conducted by the rpms analyst.Investigation revealed there were no related system errors to have occurred during the surgical procedure that would have likely caused or contributed to the reported complaint.
Event or Problem Description
It was reported that during a da vinci-assisted cholecystectomy surgical procedure, the doctor grasped the gallbladder and as he was retracting the gallbladder up over the liver, the fundus grasper instrument fell apart.It was noted that one jaw fell into the abdomen and the other jaw was very loose and floppy.An endopouch was introduced into the abdomen so that the broken part could be removed safely and the fundus grasper instrument with the floppy jaws was watched out with the camera as it was carefully removed.An x-ray was taken and nothing was found to be left behind.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 robotic coordinator informed that the below information was given to her from the surgeon as she only walked into the case after the fragment had fallen into the patient.The robotic coordinator informed that she was unaware if the fundus grasper instrument was inspected prior to use.At the time of the reported issue, it was stated that the surgeon had just placed the instrument into the system and had grasped the gallbladder when the instrument broke.As a result, the surgeon was unable to further use the instrument.It was unknown if any instrument collision occurred.The robotic coordinator informed the instrument was never removed during the case prior to the breakage as it had only been installed for the first time.Upon final removal of the fundus grasper instrument, the staff straightened the wrist and no resistance was felt as it went through the cannula.It was unknown if there was any damage observed on the cannula or instrument after it¿s removal.The robotic coordinator informed that all fragments were retrieved and that a flat abdomen lateral x-ray was taken to confirm.No additional surgical procedure were required.The robotic coordinator was not aware of the patient returning after the case due to any post-surgical complications related to retaining a foreign object.The instrument and fragments will be returning for analysis.No video/image was available for review.The procedure was completed robotically with no patient injury or harm.

• 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: 16928208
• Report Number: 2955842-2023-13624
• Device Sequence Number: 20566646
• Product Code: NAY
• UDI-Device Identifier: 00886874113622
• UDI-Public: (01)00886874113622(10)N10180321
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/07/2021

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: 478058-03
• Device Catalogue Number: 478058
• Device Lot Number: N10180321 0001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/07/2021
• Initial Report FDA Received Date: 05/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2018
• 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 Age: 6 MO
• Patient Sex: Male