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

Model Number	470380-08
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	07/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the seal accessory involved with this complaint and completed the device evaluation.Failure analysis (fa) confirmed and replicated the reported complaint.A visual inspection was performed and the seal was found to have a broken septum seal.The broken septum seal was returned.The root cause of this failure is attributed to the user mishandling/misuse.Further investigation by engineering revealed additional information.Tests were performed with an in-house stapler seal, endo wrist stapler, and stapler sheath.The stapler with sheath in place was inserted and removed ten times, in attempt to reproduce failure.Although removal of the stapler/sleeve combination was more difficult with each insertion removal cycle, the septum would not tear.Engineering could not replicate the reported failure.The septum inner diameter that directly contacts the instruments main tube during insertion and removal did not exhibit tearing.During in-house testing with in-house seal and stapler, it was observed that during stapler removal, the bottom half of the septum had a tendency to invert as a result of high friction between the sheath and septum's inner diameter.It is possible that excessive friction between seal and instrument caused inversion of the septum, which led to a tearing of the support walls and eventual separation of the septum's lower half.
Event or Problem Description
It was reported that during a da vinci-assisted appendectomy surgical procedure, the customer informed the technical service engineer (tse) that the surgeon wanted to discuss a broken piece that was found.The surgeon later called into technical support and stated they were using a 12mm seal with an 8mm reducer and believed they found all the pieces, but needed to confirm if the seal was radiopaque.The surgeon would provide pictures.The field service engineer (fse) followed up with the surgeon who informed that he was able to compare the damaged seal with the new one and believed that they had all the part.The surgeon was going to perform an x-ray as a precaution.The procedure was completing as planned with no reported injury.Intuitive surgical, inc.(isi) followed up with the surgeon and obtained the following additional information: the surgeon confirmed the procedure was a robotic assisted appendectomy.It was noted that there is no training for examination of the disposable accessory; however, the staff does look at the exterior of the accessory prior to installing.The surgeon informed that the seal was installed for approximately 20 minutes prior to the issue occurring.The surgeon informed that they believed an assist was introducing a handheld instrument through the port and the edge might have been caught and through force may have ripped off the inner blue seal.It was noted that they called technical support who assisted in retrieval of the fragment by providing images of the seal.The sirgepm informed the fragment was a big piece and was removed from the patient.After, the fragment was compared to the missing piece on the seal and it matched correctly.An x-ray was performed to ensure no fragments were left in the patient.The surgeon informed that the x-ray showed there were no fragments remaining.No instrument collision or damage to the cannula was observed during the case.The patient has not returned to the hospital for any post-surgical complications.It was noted the accessory will be returning to intuitive for analysis.An image was available; however, it was not provided.The surgeon confirmed the procedure was completed robotically with no patient injury or harm.

• Brand Name: NONE
• Common Device Name: 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: 16925236
• Report Number: 2955842-2023-13155
• Device Sequence Number: 15183581
• Product Code: NAY
• UDI-Device Identifier: 10886874112578
• UDI-Public: (01)10886874112578(10)N/A
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K140553
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/08/2021

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: 470380-08
• Device Catalogue Number: 470380
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/08/2021
• Initial Report FDA Received Date: 05/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2021
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 88 KG