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

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.

• Brand Name: DAVINCI XI
• Type of Device: PATIENT 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 Key: 13061697
• MDR Text Key: 287179892
• Report Number: 2955842-2021-11796
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110720
• UDI-Public: (01)00886874110720
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380652-41
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2021
• Initial Date FDA Received: 12/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES.
• Patient Sex: Female