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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 Date 04/16/2018
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical, inc. (isi) has not received the tip cover 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: during a da vinci-assisted surgical procedure, it was alleged that the tip cover accessory fell inside the patient. The tip cover accessory was retrieved. However, at this time, 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 monopolar curved scissors (mcs) tip cover accessory fell inside the patient. The tip cover accessory got stuck in the trocar. The customer stated that the trocar was discarded and there was no video of the procedure available. The procedure was completed with no report of patient harm, adverse outcome or injury. Intuitive surgical, inc. (isi) followed up and obtained the following additional information from the clinical sales representative (csr): the mcs tip cover accessory appeared to be installed correctly. No part of the orange surface was visible after the mcs tip cover accessory was installed. The mcs tip cover accessory was not installed beyond the orange surface or over the shaft. The mcs instrument is not available for return.
 
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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 Key7507635
MDR Text Key108374471
Report Number2955842-2018-10202
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K112263
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/17/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/11/2018
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 Received04/17/2018
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 Reuse

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