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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. PERMANENT CAUTERY HOOKINSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT

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INTUITIVE SURGICAL,INC. PERMANENT CAUTERY HOOKINSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT Back to Search Results
Model Number 420183-12
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/11/2017
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical, inc. (isi) has not received the permanent cautery hook instrument for failure analysis. Therefore, the root cause of the customer reported failure cannot be determined. A follow-up mdr will be submitted if the instrument is returned (post failure analysis 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 a fragment of the ultem from the permanent cautery hook instrument broke off and fell inside the patient and was retrieved. There was no report of patient harm, adverse outcome or injury; however, it is unknown what caused the breakage to occur.
 
Event Description
It was reported during a da vinci assisted myomectomy surgical procedure, a fragment of the ultem from the permanent cautery hook fell inside the patient. The intuitive surgical customer sales representative (csr) confirmed that the fragment was retrieved during the same da vinci procedure. There was no report of patient harm, adverse outcome or injury.
 
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Brand NamePERMANENT CAUTERY HOOKINSTRUMENT
Type of DeviceENDOSCOPIC ELECTROSURGICAL INSTRUMENT
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 Key7171888
MDR Text Key97730196
Report Number2955842-2018-00014
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 company representative
Reporter Occupation
Type of Report Initial
Report Date 12/11/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/08/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number420183-12
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 Received12/11/2017
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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