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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC NONE TIP COVER ACCESSORY

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INTUITIVE SURGICAL, INC NONE TIP COVER ACCESSORY Back to Search Results
Model Number 400180-14
Device Problem Crack (1135)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/29/2020
Event Type  malfunction  
Manufacturer Narrative
The monopolar curved scissors (mcs) tip cover accessory involved in this complaint has not been returned to intuitive surgical, inc. (isi) for evaluation. If the product is returned, or if additional information is received, a follow-up mdr will be submitted. The mcs instrument that was used during the procedure has been returned and failure analysis was completed. The instrument was found to have a deep scratch mark, approximately 0. 05¿ to the surface of the brown section of the tube extension, with material removed and missing. Any potential fragments from the brown section of the tube extension would be retained by the mcs tip cover accessory. This failure is most commonly caused by mishandling/misuse, such as excessive contact with abrasive, or hard surfaces during transport or reprocessing, or during mcs tip cover accessory installation/removal. The tip cover accessory, when used as intended, provides insulation over a section of the endowrist mcs instrument so that radio frequency (rf) energy is only available at the instrument scissor tips. A review of the site's complaint history was performed and no additional records were found for the mcs tip cover accessory. This complaint is being reported because the orange area of the mcs instrument was visible through the gray area of the mcs tip cover accessory. It is unknown if the mcs tip cover accessory had physical damage on the gray area. 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. Follow-up was attempted, but the patient information was either unknown, unavailable, not provided, or not applicable. The product is not implantable. It is unknown if the initial reporter submitted a report to the fda.
 
Event Description
It was reported that during a da vinci-assisted surgical procedure, the customer saw the orange warnings of the monopolar curved scissors (mcs) instrument through the gray section of the mcs tip cover accessory. There was no reported physical damage to the mcs tip cover accessory. The procedure was completed with no reported injury.
 
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Brand NameNONE
Type of DeviceTIP COVER ACCESSORY
Manufacturer (Section D)
INTUITIVE SURGICAL, INC
3410 central expressway
santa clara CA 95051
Manufacturer (Section G)
INTUITIVE SURGICAL, INC
3410 central expressway
santa clara CA 95051
Manufacturer Contact
david wang
3410 central expressway
santa clara, CA 95051
4085232100
MDR Report Key10745299
MDR Text Key213425464
Report Number2955842-2020-11134
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112263
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 10/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number400180-14
Device Catalogue Number400180
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/02/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/19/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 10/28/2020 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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