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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL, INC ENDOWRIST MARYLAND BIPOLAR FORCEPS Back to Search Results
Model Number 471172-16
Device Problem Thermal Decomposition of Device (1071)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/09/2022
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical, inc. (isi) received the maryland bipolar forceps instrument involved with this complaint and completed the device evaluation. Failure analysis investigation revealed that the instrument was found to exhibit thermal damage at the base of the grips on the yaw pulley. There was no damage to the conductor wire insulation. The instrument passed the electrical continuity test. The root cause is attributed to the user. A review of the instrument log for the maryland bipolar forceps instrument (pn# 471172-16 / lot# k10211213-0358) associated with this event has been performed. Per logs, the instrument was last used on (b)(6) 2022 on system (b)(4) for approximately 40 minutes. The alleged event occurred on the 2nd use of the instrument. No image or procedure video was provided for review. Based on the information available at this time, this complaint is being classified as a reportable event due to the following conclusion: it was alleged that the instrument exhibited signs indicative of thermal damage. At this time, it is unknown what caused the thermal damage to occur. While there was no harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur. Blank mdr fields: follow-up was attempted, but patient information was either unknown, unavailable, not provided, or not applicable. The expiration date is not applicable. Field is blank because the product is not implantable. Information for the blank fields is not available. Fields are not applicable.
 
Event Description
It was reported that after a da vinci-assisted radical prostatectomy with lymphadenectomy surgical procedure completed with no reported injury, the maryland bipolar forceps instrument was found to be burned on the tip. There was no reported injury. Intuitive surgical, inc. (isi) attempted to obtain additional information via follow-up. However, no further details have been received as of the date of this report.
 
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Brand NameENDOWRIST
Type of DeviceMARYLAND BIPOLAR FORCEPS
Manufacturer (Section D)
INTUITIVE SURGICAL, INC
3410 central expressway
santa clara CA
Manufacturer (Section G)
INTUITIVE SURGICAL, INC
3410 central expressway
santa clara CA
Manufacturer Contact
izabel nielson
3410 central expressway
santa clara, CA 
4085232100
MDR Report Key15048303
MDR Text Key296120769
Report Number2955842-2022-13034
Device Sequence Number1
Product Code NAY
UDI-Device Identifier00886874119792
UDI-Public(01)00886874119792(10)K10211213
Combination Product (y/n)N
Reporter Country CodeTH
PMA/PMN Number
K131861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Distributor
Reporter Occupation Other Health Care Professional
Remedial Action Other
Type of Report Initial
Report Date 06/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/18/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number471172-16
Device Catalogue Number471172
Device Lot NumberK10211213 0358
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/08/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/19/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/09/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 07/18/2022 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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