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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 Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/15/2021
Event Type  malfunction  
Manufacturer Narrative
The monopolar curved scissors (mcs) tip cover accessory will not be returned for evaluation as site has discarded the mcs tip cover accessory.Therefore, the root cause of the customer reported failure mode cannot be determined.A follow-up mdr will be submitted if additional information is obtained.A review of the site's complaint history does not show any additional complaints related to this product or this event.No image or procedure video was provided for review.Verification of the accessory product via system logs cannot be performed because accessory device product details are not captured in the system log.The mcs 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.This complaint is being reported due to the following conclusion: the mcs tip cover accessory was reportedly damaged with no evidence or claim of user mishandling/misuse.In the event the mcs tip cover accessory is compromised, it is possible for energy to discharge in an area other than the instrument tip.Per the i&a user manual "it is important to exercise caution when using a energized endowrist monopolar curved scissors instrument to help avoid unintended contact with tissue adjacent to the area to be cauterized." failure to follow these precautions will result in electrical arcs from the wrist and alternate site burns.Although there was no report of patient injury related to the reported event, the reported failure mode could cause or contribute to an adverse event if the failure were to recur.Blank mdr fields: follow-up was attempted, but the patient information in sections was either unknown, unavailable, not provided, or not applicable.The expiration date in section is not applicable.Field is not applicable because the product is not implantable.The information for blank fields in section is not available.Fields are not applicable.
 
Event Description
It was reported that during a da vinci-assisted surgical procedure, the insulation on the monopolar curved scissors (mcs) instrument was damaged and an orange marking can be seen.There were no fragments that fell inside of the patient's anatomy, and no adverse effects or injury to the patient.The procedure was completed with no reported injury.Intuitive surgical (is) contacted the site and obtained the following additional information regarding this event: the mcs tip cover was discarded and will be not returned for review.Patient demographics and medical history cannot be released due to hospital policy.No further details have been received as of the date of this report.
 
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Brand Name
NONE
Type of Device
TIP COVER ACCESSORY
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 Key12993551
MDR Text Key285830306
Report Number2955842-2021-11736
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K112263
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional
Reporter Occupation Nurse
Remedial Action Other
Type of Report Initial
Report Date 11/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number400180-14
Device Catalogue Number400180
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/15/2021
Initial Date FDA Received12/14/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/16/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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