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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. MONOPOLAR CURVED SCISSORS

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INTUITIVE SURGICAL,INC. MONOPOLAR CURVED SCISSORS Back to Search Results
Model Number 470179
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 12/27/2017
Event Type  malfunction  
Manufacturer Narrative
The instrument has not been returned to isi for failure analysis; 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. Based on the provided information, this complaint is being reported due to the following conclusion: during a da vinci assisted surgical procedure, it was alleged that the mcs instrument broke and fragments fell inside the patient. Although, all fragments were retrieved it is unknown what caused the breakage to occur.
 
Event Description
It was reported that during a da vinci-assisted nephrectomy procedure, the customer was unable to remove the monopolar curved scissors (mcs) instrument from the arm of the da vinci system. The instrument broke past the tip of the cannula and the customer was unable to pull it back through. The customer was eventually able to remove the instrument successfully. There was no report of patient harm, adverse outcome or injury. The isi clinical sales representative (csr) later stated that the customer had mentioned that the instrument had shattered. When the instrument was removed, it was noted that a piece of the shaft was missing. The customer then compared the broken instrument to a known good instrument and confirmed that no pieces were missing. The customer confirmed that all broken fragments were retrieved from the patient.
 
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Brand NameMONOPOLAR CURVED SCISSORS
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 Key7208608
MDR Text Key98197609
Report Number2955842-2018-00051
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial
Report Date 12/27/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number470179
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 Received12/27/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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