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

Model Number	478058-04
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	12/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the claim against the product by the customer noting broken jaws, an investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The fundus grasper instrument was analyzed and found to have the clevis broken, allowing the clevis pin and grip assembly to fall off.Broken piece from clevis ear was missing approximately 0.39" x 0.18".Material was not returned.The clevis pin (0.18" x 0.06") and both grip tips (0.95" x 0.19") was also not returned as a result of the broken clevis.The complaint regarding broken jaws was confirmed by failure analysis, which indicates that the device did contribute to the customer reported issue.This complaint is reportable malfunction event due to the following conclusion: failure analysis acknowledges that a fragment was missing from a portion of the device that enters the patient (distal end).Based on the information provided, there was no report from the customer that a fragment from the instrument fell into the patient during the procedure.While there was no report of 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 cholecystectomy surgical procedure, the fundus grasper instrument had broken jaws.The procedure was completed with no reported injury.An intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: at the end of the procedure the fundus grasper instrument got caught at the cannula and the customer used force to pull it out.The instrument jaws were broken and unknown if it was interoperative or broke while being docked.The instrument was inspected prior to use.The instrument was thoroughly checked, and all pieces were present, no fragments fell into the patient.There was no harm or injury to the patient.

• 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: 16354427
• Report Number: 2955842-2023-10622
• Device Sequence Number: 6270211
• Product Code: NAY
• UDI-Device Identifier: 00886874113622
• UDI-Public: (01)00886874113622(10)N10210823
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/17/2023

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: 478058-04
• Device Catalogue Number: 478058
• Device Lot Number: N10210823 0005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/17/2023
• Initial Report FDA Received Date: 02/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2021
• 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