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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 470172-16
Device Problem Thermal Decomposition of Device (1071)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/08/2022
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 (fa) did not confirm or replicate the reported complaint. The instrument passed the electrical continuity test, recognition and engagement test. The instrument moved intuitively with full range of motion in all directions. The grips opened and closed properly and performed grip function successfully. Bipolar energy cord was successfully connected to generator and instrument. Energy activation test was then conducted on system. Wet sponge was held between grips and began to smoke when energy pedal was pressed. Steam generation from the sponge indicated active power and a complete circuit. The instrument was ready for use. No loss of power and no intermittent energy were observed. Additionally, the instrument was found with thermal damage at the yaw pulley. Black char marks were observed. Any material missing is likely to be thermal induced rather than mechanically induced. Root cause is attributed to mishandling/misuse. Failure analysis found the additional failure of thermal damage to the bipolar yaw pulley to not be related to the customer reported complaint. The electrical continuity test still passed and there was no insulation damage observed to the conductor wire. A review of the site's complaint history does not show any additional complaints related to this product and/or this event. A review of the instrument log for the maryland bipolar forceps (part# 470172-16 /lot# n11200218 /sequence# (b)(4)) associated with this event has been performed. Per this review of the logs, the instrument was last used on (b)(6) 2022 on system serial # (b)(4). There was no image or video clip submitted for review. This complaint is being reported as a reportable event due to the following conclusion: there was evidence of thermal damage at the yaw pulley. Thermal damage is evidence of electrical discharge at a location other than intended. 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.
 
Event Description
It was reported that prior to the start of a da vinci-assisted surgical procedure, the maryland bipolar forceps instrument did not work when connected to bipolar cord. The procedure was with no reported injury. Intuitive surgical, inc. (isi) made multiple follow-up attempts to obtain additional information. 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 Key14251936
MDR Text Key290398341
Report Number2955842-2022-11331
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 Non-Healthcare Professional
Remedial Action Other
Type of Report Initial
Report Date 04/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number470172-16
Device Catalogue Number470172
Device Lot NumberN11200218 0124
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/21/2022
Date Manufacturer Received04/01/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/14/2020
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: 04/29/2022 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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