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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. 8 MM FENESTRATED BIPOLARFORCEPS ENDOSCOPIC ELECTROSURGICAL INSTRUMENT

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INTUITIVE SURGICAL,INC. 8 MM FENESTRATED BIPOLARFORCEPS ENDOSCOPIC ELECTROSURGICAL INSTRUMENT Back to Search Results
Model Number 470205-15
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 01/04/2018
Event Type  malfunction  
Manufacturer Narrative
The fenestrated bipolar forceps instrument has not been returned to isi for failure analysis investigations; therefore, the root cause of the customer reported failure mode cannot be determined. A follow-up mdr will be submitted if the unit is returned (post engineering evaluation) or 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 grasper broke off and fell inside the patient. The broken instrument piece was retrieved from the patient and there was no harm to the patient. However, it is unknown what caused the instrument breakage to occur.
 
Event Description
It was reported during a da vinci-assisted hysterectomy procedure, one of the graspers on the fenestrated bipolar forceps instrument broke at the base and fell inside the patient. The fragment was retrieved during the same procedure. There was no report of patient harm, adverse outcome or injury.
 
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Brand Name8 MM FENESTRATED BIPOLARFORCEPS
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 Key7226768
MDR Text Key98974778
Report Number2955842-2018-00062
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 company representative
Reporter Occupation
Type of Report Initial
Report Date 01/04/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number470205-15
Device Lot NumberN10171116 0100
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 Received01/04/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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