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

Model Number 470500-13

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/31/2023

Event Type  Injury  

Manufacturer Narrative

Based on the claim against the product by the customer noting universal seal broke loose and detached , an investigation is in progress to determine the cause of this reported event.Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.Failure analysis found the primary failure of broken luer fitting.Visual inspection revealed that the universal seal was broken.The luer fitting was found to be broken off from the lower housing of the seal.The broken piece, measuring approximately 0.432" 0.352" in size, was returned with the seal.No material appears to be missing.The root cause is attributed to the mishandling/misuse.The complaint regarding universal seal broke loose and detached was confirmed by failure analysis, which indicates that the device did contribute to the customer reported issue.This complaint is considered a reportable event due to the following conclusion: it was alleged that the universal seal broke and a fragment fell inside the patient during a da vinci assisted procedure.The fragment was retrieved during the same procedure with no patient injury.At this time, it is unknown what caused the breakage to occur.

Event Description

It was reported that during a da vinci-assisted surgical procedure, the universal seal had insufflation connection that broke loose and detached from the seal intraoperatively.A new seal needed to be opened to replace the broken seal.All pieces were retrieved from surgical field.The procedure was completed with no reported injury.Intuitive surgical inc.(isi) followed up with the initial reporter and obtained the following additional information: the instrument was inspected prior to use.There was no damage or anything out of the ordinary.The accessory was in use for 20 minutes.The fragment did not fall inside the patient during any collisions.The issue event happened prior to docking.As soon as issue was identified, the seal was replaced with a new seal.The fragments were removed by hand.A single piece of seal was dislodged, and that piece was retrieved.There was no additional procedures or post operative tests performed.The procedure was robotically completed.There was no injury to the patient.

Manufacturer Narrative

Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the insufflator tubing that was being used was stryker pneumoclear.The system was not docked yet.The seal use was for insufflation.

Event Description

Refer to h10/h11 for follow-up information.

• Brand Name: DA VINCI
• Type of Device: 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: 16829611
• MDR Text Key: 314160835
• Report Number: 2955842-2023-12235
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10886874116408
• UDI-Public: (01)10886874116408(11)221229(17)241231(10)K10221229
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/31/2023

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
• Device Operator: Health Professional
• Device Model Number: 470500-13
• Device Catalogue Number: 470500
• Device Lot Number: K10221229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2023
• Initial Date FDA Received: 04/28/2023
• Supplement Dates Manufacturer Received: 06/27/2023
• Supplement Dates FDA Received: 07/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/29/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES