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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. TIP COVER ACCESSORY ENDOSCOPIC ELECTROSURGICAL

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INTUITIVE SURGICAL,INC. TIP COVER ACCESSORY ENDOSCOPIC ELECTROSURGICAL Back to Search Results
Model Number 400180-14
Device Problem Detachment Of Device Component (1104)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 10/10/2017
Event Type  malfunction  
Manufacturer Narrative
The mcs tip cover accessory will not be returned to isi for evaluation; therefore the root cause of the customer reported failure mode cannot be determined. A follow up mdr will be submitted if the instrument is returned or if additional information is received. This complaint is being reported due to the following conclusion: it was alleged that the mcs tip cover accessory fell inside the patient. The tip cover accessory was reported to have been retrieved during the same da vinci surgical procedure. Although, there was no report of patient harm, adverse outcome or injury, it is unknown what caused the tip cover accessory to fall inside the patient.
 
Event Description
It was reported that during a da vinci-assisted right nephrectomy surgical procedure, the tip cover accessory that was installed on a monopolar curved scissors (mcs) instrument fell inside the patient. The tip cover accessory was retrieved during the same procedure with an unspecified instrument. The procedure was completed and no adverse event was reported. On (b)(4) 2017 intuitive surgical inc. , (isi) contacted the site's robotics coordinator and obtained the following additional information: the tip cover accessory that was installed on the monopolar curved scissors (mcs) instrument fell inside the patient right under the surgeon's vision. The surgeon immediately retrieved the tip cover accessory. It was also confirmed that the surgeon never took his eye off the tip cover accessory. It was also confirmed that there were no instrument collisions reported. The robotics coordinator also confirmed that the cannula and the instruments were inspected prior to use. The robotics coordinator confirmed that the procedure was completed robotically. The surgical task of cutting tissue was completed with another mcs instrument. The robotics coordinator confirmed that there was no patient harm, adverse outcome or injury. The robotics coordinator also confirmed that the tip cover accessory was contaminated and hence it was discarded.
 
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Brand NameTIP COVER ACCESSORY
Type of DeviceENDOSCOPIC ELECTROSURGICAL
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 Key6985219
MDR Text Key90763417
Report Number2955842-2017-00717
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112263
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial
Report Date 10/19/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/27/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number400180-14
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/19/2017
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 Initial

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