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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 03/22/2022
Event Type  malfunction  
Manufacturer Narrative
The fenestrated bipolar forceps instrument has been returned and evaluated by the failure analysis (fa) team. Failure analysis investigations replicated and confirmed the customer reported complaint. Failure analysis found the primary failure of thermal damage to the bipolar yaw pulley between the grips, to be related to the customer reported complaint. The instrument was found to have charring and localized melting at the grip base between the grips. The instrument passed the electrical continuity test. The root cause of thermal damage between grips instrument bipolar yaw pulley is typically attributed to the misuse, most commonly caused by insulation degradation and carbonized tissue creating a conductive path. 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 instrument (471205-17/k10211213 0281) associated with this event has been performed. Per the logs, the instrument was last used on (b)(6) 2022 in a prostatectomy procedure with dr. (b)(6). No image or procedure video was provided for review. This complaint is being reported based on the following conclusion: it was alleged that the instrument exhibited signs indicative of thermal damage. 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 the missing patient information was either unknown, unavailable, not provided, or not applicable. The expiration date is not applicable. Implant date is blank because the product is not implantable. Pma/510(k) number and adverse event are not applicable.
 
Event Description
It was reported that during central processing, the plastic on the side of the working tip of the fenestrated bipolar forceps instrument was burned and chipped away. There was no report of patient involvement. Intuitive surgical, inc. (isi) followed up with the initial reporter and obtained the following additional information: the reporter confirmed the issue was noticed after the instrument had been reprocessed and during inspection. They did not note the damage prior to reprocessing. Reporter stated that the da vinci coordinator may be able to provide further information about the procedure it was last used in. However, the coordinator did not respond.
 
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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 Key14190936
MDR Text Key289948420
Report Number2955842-2022-11209
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 03/23/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/22/2022
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 NumberK10211213 0281
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/29/2022
Date Manufacturer Received03/23/2022
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: 04/22/2022 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES.
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