FDA Adverse Event Injury Summary report: N

DA VINCI

MDR report key: 23535971 · Received November 12, 2025

Report

Report Number: 2955842-2025-44859
Event Type: Injury
Date Received: November 12, 2025
Date of Event: October 16, 2025
Report Date: November 12, 2025
Manufacturer: INTUITIVE SURGICAL, INC
Product Code: NAY
PMA / PMN Number: K112263
Removal / Correction Number: N/A
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: BIOMEDICAL ENGINEER
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. NOTE: REFER TO MEDWATCH REPORT (MDR) WITH MFR REPORT # 2955842-2025-44858 FOR MDR SUBMISSION OF THE ADVERSE EVENT/MALFUNCTION RELATED TO THE INITIAL MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT ARCING TO UNSPECIFIED TISSUE.

Description of Event or Problem · 0

IT WAS REPORTED THAT DURING AN UNSPECIFIED DA VINCI-ASSISTED PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT, INADVERTENTLY ARCED TO UNSPECIFIED TISSUE. TO ADDRESS THE ISSUE, A BACKUP MCS INSTRUMENT WAS UTILIZED WITH THE SAME MCS TIP COVER ACCESSORY. HOWEVER, THE SAME ISSUE RECURRED. AN INTUITIVE SURGICAL ,INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) WAS CONSULTED AND ADVISED THE CUSTOMER TO REPLACE THE MCS TIP COVER ACCESSORY IF PHYSICAL DAMAGE WAS OBSERVED AND FURTHER RECOMMENDED DISCONNECTING THE BIPOLAR CABLE IF THE PROBLEM OCCURRED NEAR A BIPOLAR INSTRUMENT GRIPPING TISSUE. IT IS UNKNOWN HOW THE ISSUE WAS RESOLVED, IF THERE WAS INJURY TO THE PATIENT, OR IF THE PATIENT REQUIRED ANY ADDITIONAL MEDICAL INTERVENTIONS. THE PROCEDURE WAS COMPLETED ROBOTICALLY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2592917	DA VINCI	TIP COVER ACCESSORY	NAY	INTUITIVE SURGICAL, INC	400180-14	N/A

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown	Required Intervention	DA VINCI INSTRUMENTS AND ACCESSORIES