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

Model Number	470361-08
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted thoracic surgical procedure, the customer reported that a blue rubber object was found inside the patient¿s anatomy when the endoscope was inserted into the body cavity.The surgeon was performing mediastinal tumor resection.The customer stated that there was a foreign object inside the cannula seal before the issue occurred.When the endoscope was inserted, the object was pushed out and fell into the chest cavity.The object was retrieved in the same procedure.The procedure was completed with no reported injury with a backup seal.Isi followed up with the initial reporter and obtained the following additional information: the instrument and accessory were visually checked prior to use with no issue.The object was retrieved with the video-assisted thoracoscopic surgery (vats) forceps.It was confirmed that all fragments were retrieved.No additional surgical procedure was required to remove the object.No post-operative test was performed.The procedure was completed robotically with no patient¿s injury.The patient did not return to the hospital for any post-surgical complications related to retaining a foreign object.
Additional Manufacturer Narrative
It was reported that during a da vinci-assisted thoracic procedure, a rubber object fell inside the patient¿s body.Based on the claim against the product by the customer noting a rubber object falling inside the patient¿s anatomy, an investigation is in progress to determine the cause of this reported event.Intuitive surgical, inc.(isi) did receive the port seal to perform failure analysis.The port seal accessory was analyzed and found to have a dislodged floating cylinder seal from the lower housing of the seal.As a result, the floating cylinder seal was pushed further downward causing damage to the duckbill.The customer returned the broken pieces of the duckbill separately.It did not appear to have a missing material from the duckbill.The septum of the seal was no longer visible due to the dislodged floating cylinder seal.It was unclear if there are missing pieces from the septum.The customer also returned a cylindrical blue material approximately 0.60¿ x 011¿.However, it did not appear to be a component of the duckbill or septum of the cannula seal based on the shape and the agile drawings.The material did not appear to be from the lower housing as well.This cannula seal was transferred to advanced failure analysis engineer for further analysis.The initial finding was confirmed, the seal exhibited tears and damage throughout the duckbill and septum.The duckbill was found to have the flap portion dislodged.Reassembly of the duckbill did not appear to have any obvious missing fragments.Regarding the fragment, the drawings were checked, and there was no specified form on the septum or the duckbill that matched the dimensions of the fragment.An in-house seal was disassembled, and samples of the duckbill and the septum material were gathered, cleaned, and added to the fourier transform infrared (ftir) library.The fragment that was returned was run through the ftir and was found to match with both the duckbill and septum material, and the fragment matched more closely to the duckbill material.The seal was also disassembled to determine if the fragment came from an internal component, but no obvious matches were found.The supplier engineer for the septum seal was consulted and inspected the seal and the fragment.The fragment shape and dimensions match a gate vestige from the mold for the septum.The fragment is also able to fit perfectly with the septum hole towards the large opening, where the gate vestige is typically attached during the manufacturing process.The fragment likely came from manufacturing, but the root cause was unknown and currently under investigation.Regarding the septum, it was found to be partially inside out.The septum had a tear, and the floating cylinder was forced through, pushing the septum seal partially inside out.After putting the septum right side out, the septum had a noticeable hole, and the fragment was not returned with the seal.As such, there was a potential for fragments.The hole in the septum was approximately 3.47mm x 5.85mm.The root cause for the tear in the septum is typically attributed to mishandling or misuse.An instrument log review of the product related to the complaint cannot be performed since the unit is an accessory and does not get captured by procedure logs.Images associated with this reported event were submitted for review: from the images, it is unable to identify where the object came from, as the object appears to have a long, cylindrical shape which does not appear to be present on the septum or duckbill component drawings.To best identify the object, the object and the seal should be returned so testing can be conducted on the fragment and the seal can be inspected to determine if the fragment came from the seal itself.The probable root cause is attributed to damage during use, which may result from inadvertent collisions with other instruments or hard surfaces.This issue can be resolved by using an alternate instrument to complete the procedure.No additional actions are currently required given that this issue will continue to be tracked.This complaint is considered a reportable event due to the following conclusion: it was alleged that the port 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.While there was no harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur as unintended fragment(s) falling into the patient may require surgical intervention.

• 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: 15921662
• Report Number: 2955842-2022-15749
• Device Sequence Number: 2532509
• Product Code: GCJ
• UDI-Device Identifier: 10886874112547
• UDI-Public: (01)10886874112547(10)M11220508
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/07/2022

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: M11220508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/07/2022
• Initial Report FDA Received Date: 12/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2022
• 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: 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