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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST MEGA SUTURECUT ND

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INTUITIVE SURGICAL, INC ENDOWRIST MEGA SUTURECUT ND Back to Search Results
Model Number 471309-15
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Foreign Body In Patient (2687)
Event Date 11/15/2021
Event Type  Injury  
Event Description
It was reported that during a da vinci-assisted umbilical hernia surgical procedure, a mega suture needle driver jaw broke inside the patient. The surgeon did not see the instrument break, but it was recognized while the surgeon attempted to use the instrument again. The caller stated that they did fluoroscopy and located the jaw inside the patient but the surgeon elected not to retrieve the fragment as it was very small, and it might cause injury trying to retrieve it. The procedure was completed. Isi made multiple follow-up attempts to obtain additional information. However, no further details have been received as of the date of this report.
 
Manufacturer Narrative
Intuitive surgical, inc. (isi) has not received the mega suture needle driver instrument for evaluation although it has been requested for return. Therefore, the root cause of the customer reported failure mode has not been determined. A follow-up mdr will be submitted if the product is returned and evaluated and/ or if additional information is received. A review of the site's complaint history does not show any additional complaints related to this product. An instrument log review would not show any information related to instrument breakage. No image or video clip for the reported event was submitted for review. This complaint is being reported due to the following conclusion: during a da vinci-assisted surgical procedure, it was alleged that the a mega suture needle driver jaw broke inside the patient. The fragment was not retrieved. At this time it is unknown what caused the breakage to occur. Blank mdr field information: follow-up was attempted, but the patient information for blank fields either unknown, unavailable, not provided, or not applicable. The expiration date is not applicable. The product is not implantable. It is unknown if the initial reporter submitted a report to the fda. Insufficient product information was provided in order to obtain the date of manufacture.
 
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Brand NameENDOWRIST
Type of DeviceMEGA SUTURECUT ND
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 Key13023498
MDR Text Key287787454
Report Number2955842-2021-11758
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 11/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number471309-15
Device Catalogue Number471309
Device Lot NumberN11210818 0061
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/30/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/29/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 12/16/2021 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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