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

Model Number	470361-08
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the current information provided, the cause of the reported safety concern ¿about the stopcock switch on the xi cannula seals being so loose they randomly will move, either allowing gas to escape or shutting off the insufflation to the abdomen¿ remains unknown.There is no rma associated with this complaint and therefore, there are no isi products expected to return for evaluation.A complaint investigation could not be performed since the site and product information could not be collected at this time.Also, a system log review was not performed since it is not relevant to the alleged complaint.No image or video was provided to isi for review.If additional information becomes available, the complaint will be re-evaluated.This complaint is being reported due to the following conclusion: it was reported that the stopcock switch on the xi cannula seals being loose would randomly allow for gas to escape or result in a shutting off of the insufflation to the abdomen.While there was no reported harm or injury to a patient, this complaint is being reported as a malfunction, as the observed failure mode could potentially cause or contribute to an adverse event if it were to recur.
Event or Problem Description
It was reported to intuitive surgical, inc.(isi) complaints from surgeons/staff at more than 1 hospital about the stopcock switch on the xi cannula seals being so loose they randomly will move, either allowing gas to escape or shutting off the insufflation to the abdomen.Upon inspection by the customer, the xi cannula seals were noted to be very loose, and the smallest movement by the instrument arm will cause this to happen.Reportedly, this has occurred while the surgeon is working, then the patient¿s abdomen quickly loses gas with instruments in.It is unknown whether any serious injury to the patient has occurred due to abdomen quickly losing gas during the procedures.
Additional Manufacturer Narrative
Corrected information can be found in fields e1, e3, and g2 additional information can be found in field h10: intuitive surgical, inc.(isi) received the following additional information from the isi representative that initially reported the issue: the isi representative was present for a procedure when the first assist for the procedure noted that the cannula seal¿s gray switch was loose and would slip back and forth resulting in it inadvertently opening.The first assist noted that they had seen the issue occur during other procedures across multiple hospitals in the area as the first assist would regularly work at multiple different hospitals with multiple different surgeons.The first assist indicated that they were able to quickly switch the seal back to its intended position and continue with the procedure whenever the issue occurred.The isi representative did not recall any instance of patient harm, injury, or adverse outcome occurring and indicated that he does not believe there were any adverse events or procedure conversions as a result of the reported issue.The isi representative also indicated that he does not recall any instance of patient harm ever being reported to him as a result of the reported problem.The isi representative indicated that he did not recall the specific procedure type or the names of the surgeon and/or first assist for the event where the issue was initially reported to him.
Event or Problem Description
Refer to h10/h11 for follow-up information.

• 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: 14876504
• Report Number: 2955842-2022-12647
• Device Sequence Number: 5690640
• Product Code: GCJ
• UDI-Device Identifier: 10886874112547
• UDI-Public: (01)10886874112547(10)L10200228
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 470361-08
• Device Catalogue Number: 470361
• Device Lot Number: L10200228
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/27/2020
• Supplement Date Received by Manufacturer: 10/27/2020
• Initial Report FDA Received Date: 06/30/2022
• Supplement Report FDA Received Date: 08/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2020
• 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 Sex: Unknown