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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST PERMANENT CAUTERY SPATULA

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INTUITIVE SURGICAL, INC ENDOWRIST PERMANENT CAUTERY SPATULA Back to Search Results
Model Number 470184-13
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); Unspecified Tissue Injury (4559)
Event Date 11/30/2021
Event Type  Injury  
Event Description
It was reported that during a da vinci-assisted right upper pulmonary lobectomy procedure for a malignant lung tumor, an injury to the bronchial artery occurred during the dissection of the vascular sheath with a fenestrated bipolar forceps (fbf) instrument and a permanent cautery spatula (pcs) instrument resulting in bleeding. The surgeon thinks the injury occurred due to contact of the energized pcs with the vessel. Per the surgeon, there was no malfunction of an isi instrument or system that caused the bleeding. The surgeon also confirmed that there was no unexpected movement of an instrument or system arm that caused the bleeding. There were adhesions in the patient, but it is unclear if these adhesions were a direct cause of the injury. It is unknown if there were any relevant pre-existing medical illness that may have contributed to the injury. The surgeon initially tried to stop the bleeding by applying direct pressure with lung tissue and gauze but then converted the procedure to open to achieve hemostasis. The amount of blood loss is unknown. The instruments are not available for analysis as the vascular injury was not caused by a malfunction of an instrument or system. No video is available to isi for review.
 
Manufacturer Narrative
Based on the current information provided, the cause of the intra-operative complication is unknown. There is no allegation that a malfunction of a da vinci system, instrument, or accessory occurred. Therefore, no products are expected for return to isi for evaluation. If additional information is received, a follow-up mdr will be submitted. 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 system and instrument logs has been performed. There were no observed events in the available system logs that would suggest a product issue, and logged events are in line with normal system functionality. Although none of the reusable instruments were reused in subsequent procedures, a site review shows no complaint filed against the instruments. No image or video clip for the reported event was submitted for review. This complaint is a reportable adverse event due to the following: during a da vinci-assisted pulmonary lobectomy procedure, the bronchial artery was injured during dissection with a permanent cautery spatula (pcs) and a fenestrated bipolar forceps (fbf). The surgeon believes that the complication occurred while force was being directly applied to the vessel by the energized pcs instrument resulting with bleeding. According to the surgeon, there was no malfunction of a da vinci system, instrument or accessory that caused the injury. The surgeon electively converted the procedure to open surgery to achieve hemostasis. The cause of the intra-operative complication is unknown.
 
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Brand NameENDOWRIST
Type of DevicePERMANENT CAUTERY SPATULA
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 Key13080858
MDR Text Key288283998
Report Number2955842-2021-11798
Device Sequence Number1
Product Code NAY
UDI-Device Identifier00886874112328
UDI-Public(01)00886874112328(10)N10210222
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K131861
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 11/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number470184-13
Device Catalogue Number470184
Device Lot NumberN10210222 0051
Was Device Available for Evaluation? No
Date Manufacturer Received11/30/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 12/23/2021 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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