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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 Arcing (2583)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/18/2021
Event Type  malfunction  
Event Description
It was reported that during a da vinci-assisted hysterectomy-benign surgical procedure, a spark was noted between the fenestrated bipolar forceps (fbf) instrument and the monopolar curved scissors (mcs) instrument. The customer replaced both instruments with the backup instruments. The site continued to complete the procedure as planned with no injury to the patient. Intuitive surgical, inc. (isi) followed up with the initial reporter (da vinci coordinator) and obtained additional information: the surgeon was using the mcs instrument near the fbf instrument that was holding the tissue. A flash and spark with flame occurred for less a second. It was believed that two instruments were close enough to make a contact while being energized. There was no patient injury.
 
Manufacturer Narrative
Intuitive surgical, inc. (isi) has not yet been received the monopolar curved scissors (mcs) instrument or the mcs tip cover for failure analysis to be performed. Therefore, the root cause of the customer reported failure has not be determined. The fenestrated bipolar forceps instrument also has not been received yet. A follow-up mdr will be submitted if the instruments or the accessory are returned (post failure analysis evaluation) or if additional information is received. A review of the site's complaint history does not reveal any additional complaints involving this product or this event. Verification of the accessory product via system logs cannot be performed because accessory device product details are not captured in the system log. No image or procedure video was provided for review. This complaint is being reported due to the following conclusion: it was alleged that the instruments sparked with no evidence or claim of user mishandling or misuse. In the event the tip cover 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. The allegation could be related to the potential for electrical discharge at a location other than intended. 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.
 
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Brand NameNONE
Type of DeviceTIP 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 Key12981834
MDR Text Key288390545
Report Number2955842-2021-11728
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,Health Professional
Reporter Occupation Other Health Care Professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 11/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2021
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? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/08/2022
Was Device Evaluated by Manufacturer? Yes
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 Treatment Data
Date Received: 12/12/2021 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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