MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI ENERGY; SYNCHROSEAL

Model Number 480440-06

Device Problems Material Fragmentation (1261); Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/05/2024

Event Type  Injury  

Manufacturer Narrative

No product has been returned to intuitive surgical, inc.(isi) for evaluation.A system log review did not reveal any system errors that would have caused or contributed to the reported event.

Event Description

On 02/26/2024, intuitive surgical, inc.(isi) received mw5151229 stating: "small screw from davinci synchroseal fell off inside patient.Surgeon removed screw immediately.Davinci rep made aware.Device removed from the field.".

Manufacturer Narrative

Additional information/device evaluation: initial failure analysis: the product was returned to intuitive surgical, inc.(isi) and failure analysis (fa) found the primary failure of dislodged distal washer be related to the customer reported complaint.For clarification, the instrument was found to have one of the distal washers to be dislodged.The dislodged distal washer was not returned with the instrument.The housing was removed and there were no missing screws at the proximal end.Additional observation not reported by site that is related to the primary failure: the instrument was missing the jaw cover.Demographics: date of birth (b)(6) 1951, female, 90.3 kg, previous history of hiatal hernia.Image review: based on the images provided we can confirm that the synchroseal in image 2 is missing the washer that was retrieved and is pictured in the plastic cup in image 1.Annex b: added b15 - analysis of data provided by user/third party and b01 - testing of actual/suspected device.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

Device evaluation: advanced failure analysis was performed and the initial failure analysis findings were confirmed.The distal washer was found to be dislodged.The jaw cover was also confirmed to be missing, but it isn't necessarily related to the primary code of distal washer dislodged.The wrist discs were disassembled, and remnants of the rubber washer were found in the area around wrist discs, indicating that the jaw cover likely came loose due to collisions with other instruments etc.During the procedure, and unlikely that it was never installed during manufacturing.Additionally, the pivot pin was inspected, and it looked appropriately swaged.Correction: annex d - retract code d15.

Event Description

Refer to h10/h11 for follow-up information.

• Brand Name: DA VINCI ENERGY
• Type of Device: SYNCHROSEAL
• 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: 18818635
• MDR Text Key: 336685040
• Report Number: 2955842-2024-12009
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 480440-06
• Device Catalogue Number: 480440
• Device Lot Number: L90220130 0011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES.
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 90 KG