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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 03/30/2022
Event Type  malfunction  
Event Description
It was reported that during central processing, the customer conducted an inspection and observed thermal damage on the pulley cover of the maryland bipolar forceps instrument. No patient involvement. Intuitive surgical, inc. (isi) followed up with the site and obtained the following additional information regarding the reported event: there was no issue with the instrument related to thermal damage, unintended energy discharge, arcing and no known inadvertent contact with another energy instrument during the last procedure usage on (b)(6) 2022 using system (b)(4). No conductor wire damage was confirmed upon inspection.
 
Manufacturer Narrative
Concomitant medical products- intuitive surgical, inc. (isi) received the maryland bipolar forceps (mbf) instrument involved with this complaint and completed the device evaluation. The reported event was confirmed through failure analysis (fa) investigation. The instrument was found to have thermal damage at the bipolar yaw pulley. Black char marks were observed. Investigation indicated that any material missing is likely to be thermally induced rather than mechanically induced. No insulation damage observed to the conductor wire. The instrument was tested for electrical continuity and passed. The known cause of the observed thermal damage at the bipolar yaw pulley is attributed to instrument mishandling and misuse. 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 submitted image was performed by an isi failure analysis engineer (fae). The following additional information was provided: no clear damage on the maryland bipolar forceps instrument grips or conductor wire can be visualized. A conclusive determination could not be made based on this analysis. A review of the instrument log for the maryland bipolar forceps instrument (part# 471172-16 / lot# k10211012-0524) associated with this event has been performed. Per logs, the instrument was last used for a prostatectomy - radical w/o lymphadenectomy procedure on (b)(6) 2022 on system (b)(4). The instrument has 11 remaining usable lives with no subsequent use recorded. This complaint is considered a reportable event due to the following conclusion: it was alleged that the instrument exhibited signs indicative of thermal damage. Fae's analysis of the submitted image was inconclusive. Fa investigation confirmed thermal damage at the bipolar yaw pulley. 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.
 
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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 Key14257607
MDR Text Key290470593
Report Number2955842-2022-11361
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K131861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Company Representative
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 03/31/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/02/2022
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 NumberK10211012 0524
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/15/2022
Date Manufacturer Received03/31/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/07/2021
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: 05/02/2022 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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