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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST FENESTRATED BIPOLAR FORCEPS

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INTUITIVE SURGICAL, INC ENDOWRIST FENESTRATED BIPOLAR FORCEPS Back to Search Results
Model Number 470205-15
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/08/2018
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, a piece of the fenestrated bipolar forceps instrument broke off and fell into 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. This report does not admit that the report or information submitted under this report constitutes an admission that the device, intuitive surgical or intuitive surgical employees, caused or contributed to the reportable event.
 
Event Description
It was reported that during a da vinci assisted incisional hernia repair procedure, during use of the fenestrated bipolar forceps instrument, the instrument broke causing a piece of the instrument to fall into the patient. The broken instrument piece was retrieved during the same surgical procedure and the planned surgical procedure was completed with a replacement instrument. On (b)(6) 2018 intuitive surgical, inc. (isi) contacted the site's assistant nurse manager regarding the reported event. According to the nurse manager, she was not present for the surgical procedure and indicated that she was unable to provide any additional information regarding the reported event at this time.
 
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Brand NameENDOWRIST
Type of DeviceFENESTRATED BIPOLAR FORCEPS
Manufacturer (Section D)
INTUITIVE SURGICAL, INC
950 kifer road
sunnyvale CA 94086
Manufacturer (Section G)
INTUITIVE SURGICAL, INC
950 kifer road
sunnyvale CA 94086
Manufacturer Contact
tabitha reed
950 kifer road
sunnyvale, CA 94086
4085232100
MDR Report Key7315479
MDR Text Key101708719
Report Number2955842-2018-10036
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 health professional
Reporter Occupation
Type of Report Initial
Report Date 02/08/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/05/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number470205-15
Device Lot NumberN11171116
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 Received02/08/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/16/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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