MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC NONE; CANNULA SEAL

Model Number	470361-08
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted gastric bypass surgical procedure, the customer was putting the camera in when they saw a piece of the blue cannula seal had fallen into the patient.The customer retrieved the fragment with a backup instrument.The fragment did not fall into the patient during an instrument tip/accessory collision.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: all fragments were retrieved.No other pieces were observed to fall into the patient and no pieces were noticed throughout the duration of the procedure.There was no additional surgical procedure required to remove the fragment and there was no post-operative tests like an x-ray or ultrasound performed to check for remaining fragments.The surgeon felt that the fragment broke from the cannula seal, but the customer was unable to find a similar part on an unaltered seal.The fragment was noticed as soon as the camera was introduced into the abdomen.The cannula seal was inspected visually prior to start of procedure and had no damage noted.The surgical staff did not feel any resistance upon removal of the instrument through the cannula and did not notice any damage to the cannula after the event occurred.There was no patient injury and the patient had not returned to the hospital due to experiencing any post-surgical complications related to retaining a foreign object.The procedure was completed robotically.
Additional Manufacturer Narrative
Based on the claim against the product noting a fragment fell, 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 cannula seal accessory was analyzed and failure analysis investigation did not replicate nor confirm the customer reported complaint.The piece of blue seal mentioned in complaint was not returned with rma.No product issue was identified and the visual inspection could not identify any missing pieces of blue seal.

• Brand Name: NONE
• Common Device Name: CANNULA SEAL
• 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: 17065176
• Report Number: 2955842-2023-15662
• Device Sequence Number: 6739062
• Product Code: GCJ
• UDI-Device Identifier: 10886874112547
• UDI-Public: (01)10886874112547(10)M16221201
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K133845
• 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): 05/08/2023

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: 470361-08
• Device Catalogue Number: 470361
• Device Lot Number: M16221201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/08/2023
• Initial Report FDA Received Date: 06/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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: 55 YR
• Patient Sex: Male
• Patient Weight: 87 KG