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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI MONOPOLAR CURVED SCISSORS

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INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI MONOPOLAR CURVED SCISSORS Back to Search Results
Model Number 420179-22
Device Problem Thermal Decomposition of Device (1071)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/14/2019
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical, inc. (isi) received the monopolar curved scissors associated with the complaint and completed the investigation. Failure analysis investigations replicated and confirmed the customer reported complaint of damaged cable at tip. Failure analysis found the primary failure of broken grip cable. The instrument was found to have a broken grip cable at the distal idler pulley. The distal idler pulley spun freely and did not exhibit any damage. Root cause of broken grip cable is attributed to a component failure. Additional observation not reported by site: the instrument was found to have thermal damage on the orange tube extension at the distal end. Root cause 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 part# 420179-22/lot# n11181017 0768 associated with this event has been performed. Per logs, the monopolar curved scissors was last used on (b)(6) 2019 on system (b)(4) with 3 lives remaining. The review of the provided image confirmed the damaged cable. Based on the additional information obtained from failure analysis investigation, this complaint is being reported due to the following conclusion: it was alleged that the instrument exhibited signs indicative of thermal damage. At this time, it is unknown what caused the thermal damage to occur. 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.
 
Event Description
It was reported that during da vinci-assisted surgical procedure, the monopolar curved scissors was found to have a damaged cable at the tip. A backup instrument of the same kind was used to continue. The procedure was completed with no reported injury. Intuitive surgical, inc. (isi) followed up with the initial reporter to obtain the information regarding patient demographics, relevant testing, and medical history; however, the reporter was not able to provide that information. Per customer, the monopolar curved scissors was inspected prior to use and no anomaly was noted. There was no report of any collision or arcing.
 
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Brand NameENDOWRIST;DAVINCI SI
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 Key14247569
MDR Text Key290364573
Report Number2955842-2022-11311
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K180033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign
Reporter Occupation Non-Healthcare Professional
Remedial Action Other
Type of Report Initial
Report Date 03/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number420179-22
Device Catalogue Number420179
Device Lot NumberN11181017 0768
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/28/2022
Date Manufacturer Received03/29/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/15/2018
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: 04/29/2022 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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