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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 471205-17
Device Problem Thermal Decomposition of Device (1071)
Patient Problem Insufficient Information (4580)
Event Date 03/14/2022
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical, inc. (isi) received the fenestrated bipolar forceps instrument involved with this complaint and completed the device evaluation. Failure analysis (fa) confirmed the reported complaint of "burnt rubber at the tip. " the instrument was found to have thermal damage on the bipolar yaw pulley. The known common cause of this failure is due to instrument mishandling and misuse such as collision with another energized instrument. 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 fenestrated bipolar forceps (part# 471205-17 / lot# k10210907 / sequence# 0133) associated with this event has been performed. Per this review of the logs, the instrument was last used for a procedure on (b)(6) 2022 on system serial# (b)(4). Based on this review, the instrument was not used in the reported event date or in any subsequent procedure(s) after its last usage. There was no image or video clip submitted for review. Based on the additional information obtained from failure analysis investigations, this complaint is being reported as a reportable event due to the following conclusion: it was alleged that the instrument exhibited signs indicative of thermal damage. Failure analysis confirmed thermal damage on 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.
 
Event Description
It was reported that prior to the start of a da vinci-assisted surgical procedure, routine inspection of the fenestrated bipolar forceps instrument identified burnt rubber at the tip. No patient involvement.
 
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Brand NameENDOWRIST
Type of DeviceFENESTRATED 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 Key14108485
MDR Text Key289246031
Report Number2955842-2022-11029
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,Health Professional
Reporter Occupation Other Health Care Professional
Remedial Action Other
Type of Report Initial
Report Date 03/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number471205-17
Device Catalogue Number471205
Device Lot NumberK10210907 0133
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/24/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/14/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/02/2021
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: 04/13/2022 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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