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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 400180-14
Device Problem Detachment Of Device Component (1104)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 04/18/2018
Event Type  malfunction  
Manufacturer Narrative
The tip cover accessory will not be returned for evaluation as it was discarded by the customer. Therefore, the root cause of the customer reported failure mode cannot be determined. A follow up mdr will be submitted if additional information is received. This complaint is being reported due to the following conclusion: it was alleged that during a da vinci-assisted surgical procedure, the mcs tip cover accessory fell off inside the patient. The surgical staff was able to retrieve the mcs tip cover accessory during the same surgical procedure. However, at this time, the root cause of the customer reported failure mode is unknown.
 
Event Description
It was reported that during a da vinci-assisted surgical procedure, the monopolar curved scissors (mcs) tip cover accessory came off. The tip cover accessory was retrieved during the same procedure. The procedure was completed with no report of patient harm, adverse outcome or injury. Intuitive surgical, inc. (isi) followed up with the customer and obtained the following additional information: the clinical sales representative (csr) visited the site and confirmed that the tip cover accessory was installed correctly. The surgeon alleged that the issue may have been caused while the instrument was manipulating heavy adipose (fatty) tissue, which was particularly greasy to the eye.
 
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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 Key7499759
MDR Text Key107839580
Report Number2955842-2018-10189
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeGB
PMA/PMN Number
K112263
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation
Type of Report Initial
Report Date 04/18/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/09/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number400180-14
Device Lot NumberM11180102
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/18/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/28/2017
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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