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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. 8MM CANNULA SEAL ENDOSCOPIC ACCESSORY

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INTUITIVE SURGICAL,INC. 8MM CANNULA SEAL ENDOSCOPIC ACCESSORY Back to Search Results
Model Number 400077
Device Problems Detachment Of Device Component (1104); Device Or Device Fragments Location Unknown (2590)
Patient Problem Foreign Body In Patient (2687)
Event Date 01/04/2018
Event Type  Injury  
Manufacturer Narrative
Intuitive surgical inc. Has not received the cannula seal accessory for failure analysis. Therefore, the root cause of the customer reported failure mode cannot be determined. If additional information is received, a follow-up mdr will be submitted. This complaint is being reported due to the following conclusion: it was alleged that during a da vinci-assisted surgical procedure, a piece from the cannula seal accessory was missing and it is unknown if it fell inside the patient. The missing piece was not found during the procedure. At this time, the location of the missing piece is unknown and it is unclear if any piece of the cannula seal was retained inside the patient.
 
Event Description
It was reported that during a da vinci-assisted prostatectomy procedure, the customer noted a missing green cannula seal. The customer was unsure if the cannula seal was missing at the start of the procedure or if during the procedure the cannula seal fell inside the patient. The customer contacted the intuitive surgical, inc. (isi) technical support to inquire if the cannula seal was x-ray detectable and was informed that it was radiolucent. On (b)(4) 2018, isi obtained the following additional information from the registered nurse (rn) who was present during the surgical procedure: she indicated that the cannula seal was not inspected prior to starting the procedure. They noted that gas was escaping when they inserted the trocar, they removed the trocar with the cannula seal and noted that the clear part of the cannula seal was missing. They searched for the missing part inside the patient but could not find the missing cannula seal. They don't know if the cannula seal fell inside the patient or if it was missing prior to starting the procedure. They replaced the cannula seal and the procedure was completed successfully. There were no report of patient harm, adverse outcome or injury.
 
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Brand Name8MM CANNULA SEAL
Type of DeviceENDOSCOPIC ACCESSORY
Manufacturer (Section D)
INTUITIVE SURGICAL,INC.
sunnyvale CA
Manufacturer (Section G)
INTUITIVE SURGICAL, INC.,
950 kifer rd
sunnyvale CA
Manufacturer Contact
tabitha reed
950 kifer rd
sunnyvale, CA 
4085232420
MDR Report Key7229392
MDR Text Key98628778
Report Number2955842-2018-00067
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K050369
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 01/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/30/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number400077
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/04/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 01/30/2018 Patient Sequence Number: 1
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