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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST SP MONOPOLAR CURVED SCISSORS

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INTUITIVE SURGICAL, INC ENDOWRIST SP MONOPOLAR CURVED SCISSORS Back to Search Results
Model Number 430004-53
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/22/2021
Event Type  malfunction  
Event Description
It was reported that prior to starting (pre-anesthesia) a da vinci-assisted myomectomy surgical procedure, the monopolar curved scissors (mcs) instrument was found to have broken sheath before use. A backup instrument of same kind was used. The procedure was completed. Intuitive surgical, inc. (isi) followed up with the initial reporter and obtained the following additional information: the issue was identified prior to starting procedure, so the patient was not involved. There was no report of fragments falling from the device while used within a patient. The patient has not returned to the hospital due to experiencing any post-surgical complications related to retaining a foreign object. Information regarding patient demographics, relevant testing, and medical history were requested however, the reporter was not able to provide that information.
 
Manufacturer Narrative
Intuitive surgical, inc. (isi) received the monopolar curved scissors instrument involved with this complaint and completed the device evaluation. Failure analysis investigations replicated and confirmed the customer reported complaint. Failure analysis found the primary failure of broken grip tip to be related to the customer reported complaint. For clarification, the instrument was found to have a broken grip at the distal end. A piece approximately 0. 099" x 0. 083" was found to be broken off the distal end. The broken piece was not returned. The root cause of broken instrument grips -tips is typically attribute to user mishandling or misuse, such as excess force applied to the instrument jaws. A review of the instrument log for the monopolar curved scissors instrument (part # 430004-53/lot# s10210603 0008) associated with this event has been performed. Per logs, the instrument was last used on (b)(6) 2021, on system sp0081. The instrument had 11 uses remaining after last use. In addition, a review of the site's complaint history does not show any additional complaints related to this product and/or this event. No image or video clip for the reported event was submitted for review. This complaint is being reported due to the following conclusion: it was acknowledged that a fragment was missing from a portion of the device that enters the patient (distal end). Based on the information provided, there was no report from the customer that a fragment from the instrument fell into the patient during the procedure. While there was no report of 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 NameENDOWRIST SP
Type of DeviceMONOPOLAR CURVED SCISSORS
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 Key13694511
MDR Text Key288858997
Report Number2955842-2022-10527
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K182371
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 02/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/08/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number430004-53
Device Catalogue Number430004
Device Lot NumberS10210603 0008
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/26/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/09/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/03/2021
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: 03/08/2022 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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