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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL, INC ENDOSCOPIC ELECTROSURGICAL INSTRUMENT TIP COVER ACCESSORY Back to Search Results
Model Number 400180
Device Problem Detachment Of Device Component (1104)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Type  malfunction  
Manufacturer Narrative
The tip cover accessory nor the instrument will be returned to isi for failure analysis evaluation; therefore, the root cause of the customer reported failure mode cannot be determined. A follow-up mdr will be submitted if the instrument or accessory are returned (post engineering evaluation) or if additional information is received. This complaint is being reported due to the following conclusion: during a da vinci-assisted surgical procedure, it was alleged that the tip cover accessory fell inside the patient. Although, the tip cover accessory was retrieved and no patient harm, adverse outcome or injury was reported, 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 surgical procedure, the surgeon noted that the tip cover accessory was inside the patient. The tip cover accessory was retrieved with a laparoscopic grasper during the same da vinci surgical procedure. The planned surgical procedure was completed and no patient harm, adverse outcome, or injury was reported. Intuitive surgical, inc. (isi) followed up with the customer and obtain the following additional information: the customer confirmed that procedure was completed robotically and the fragment was retrieved during the same procedure without patient harm. Furthermore, it was confirmed that both the monopolar curved scissors (msc) instrument nor the tip cover accessory will be returned to isi for evaluation. The customer was not able to confirm the date of the event.
 
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Brand NameENDOSCOPIC ELECTROSURGICAL INSTRUMENT
Type of DeviceTIP COVER ACCESSORY
Manufacturer (Section D)
INTUITIVE SURGICAL, INC
950 kifer rd.
sunnyvale
Manufacturer (Section G)
INTUITIVE SURGICAL, INC
950 kifer rd.
sunnyvale
Manufacturer Contact
tabitha reed
950 kifer rd.
sunnyvale 
4085232100
MDR Report Key7492711
MDR Text Key107716990
Report Number2955842-2018-10183
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 04/12/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number400180
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 Received04/12/2018
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

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