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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI PATIENT SIDE CART, 4-ARM

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INTUITIVE SURGICAL, INC DAVINCI XI PATIENT SIDE CART, 4-ARM Back to Search Results
Model Number 380652-41
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Burn(s) (1757); Necrosis (1971)
Event Date 11/22/2021
Event Type  Injury  
Manufacturer Narrative
Intuitive surgical, inc. (isi) has not received either of the instruments noted for evaluation. At this time, the root cause 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. An isi field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint and to perform electrical safety, ground, and leakage tests. The reported complaint was not confirmed and all tests passed based on the field evaluation. The isi fse confirmed with the customer that the appropriate grounding pads were used during this event and that no third party products were used. The system was tested and verified as ready for use. A review of the system/instrument logs for the procedure date has been performed: no errors occurred during the procedure. Additionally, as of (b)(6) 2021, none of the energy instruments used during the procedure were used again in subsequent procedures. A site history review confirmed that no additional complaints were made against these instruments. No images or video footage were provided for isi's evaluation. This complaint is being reported due to the following conclusion: during a da vinci-assisted surgical procedure, it was reported that the patient allegedly sustained either a port site burn or port site necrosis. It is unknown how severe the potential patient burn or necrosis was and what treatment, if any, was administered. While the surgeon reported that she believes the complication was tissue necrosis, the true nature of the reported injury and its root cause remain unknown.
 
Event Description
An unspecified hospital employee reported that after a da vinci-assisted malignant hysterectomy surgical procedure, possible burning around one of the trocar sites was identified. The site initially reported that they believed a monopolar instrument may have arced to the trocar. Shortly after the initial complaint was reported to intuitive surgical, inc. (isi), the operating surgeon told an isi representative that the reported observation was most likely trocar site necrosis related to the length of the case. The site's sterile processing department (spd) is reportedly holding the monopolar energy instruments that were used during the procedure (monopolar curved scissors part #: (b)(6), lot #: n10210802-627. Permanent cautery hook part #: 420183-14 - lot #: n10180904-687) and indicated that they would return the instruments. The instruments have not been returned as of the date of this report. Isi made multiple follow-up attempts to obtain additional information. However, no further details have been received as of the date of this report.
 
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Brand NameDAVINCI XI
Type of DevicePATIENT SIDE CART, 4-ARM
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 Key13061697
MDR Text Key287179892
Report Number2955842-2021-11796
Device Sequence Number1
Product Code NAY
UDI-Device Identifier00886874110720
UDI-Public(01)00886874110720
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
Report Date 11/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number380652-41
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/24/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/06/2019
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: 12/22/2021 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES.
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