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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 Insufficient Information (4580)
Event Date 03/22/2022
Event Type  malfunction  
Manufacturer Narrative
The maryland 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 to be related to the customer reported complaint. The instrument was found to have thermal damage on the bipolar yaw pulley. The instrument passed the electrical continuity test. Root cause of this failure is attributed to mishandling/misuse. Additional observation not reported by site was that related to the primary failure was that the instrument was found to have signs of thermal damage to the conductor wire¿s insulation at the distal end. The conductor wire was not exposed as a result. The damaged insulation is near the bipolar yaw pulley thermal damage failure. The root cause of this failure is attributed to mishandling/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 instrument log for the maryland bipolar forceps instrument (470172-16/n10180713 0060) associated with this event has been performed. Per the logs, the instrument was last used on (b)(6) 2022 in a radical prostatectomy with lymphadenectomy procedure. 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. Failure analysis performed evaluation and confirmed the thermal damage. It is unknown if the thermal damage occurred as a result of central processing, or if it occurred intraoperatively. While there was no reported harm or injury to a 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 maryland bipolar forceps instrument was burned and chipped. 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. No further information was obtained.
 
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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 Key14190938
MDR Text Key289948292
Report Number2955842-2022-11210
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 Number470172-16
Device Catalogue Number470172
Device Lot NumberN10180713 0060
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 Manufactured07/11/2018
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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