MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST SP; MARYLAND BIPOLAR FORCEPS

Model Number	430152-02
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The bipolar instrument was analyzed and found to have thermal damage at the molded insulator.The lower grip's over molded insulator appears to have melted, and the underlying metal base is visible, with burn marks.The energy delivery and electrical continuity were tested and passed.The housing was removed for inspection and found to have no damage.The instrument passed the recognition and engagement tests.The instrument moved intuitively with a full range of motion in all directions.The grips opened and closed properly.The housing was removed for inspection and found to have no damage.The probable root cause of thermal damage is attributed to carbonized tissue on the grips of this bipolar instrument creating a conductive path during use.Thermal damage can also result due to inadvertent energy application from a monopolar instrument.This issue can be resolved by using an alternate instrument to complete the procedure.
Event or Problem Description
It was reported that during central processing, the maryland bipolar forceps instrument had a chip at the tip.There was no report of patient involvement or patient injury.Intuitive followed up with the initial reporter and obtained the following additional information: the exact time the damage occurred is unknown, as it was only noticed after the item was sent to the central sterile department.There have been no reports of fragments falling, and no fragments have been found or reported.Additionally, there have been no complications reported, and the patient has not returned to the hospital.From my recollection, the damage was a very small crack, but i do not remember if anything was missing.There are no photographs or images available to provide further detail.

• Brand Name: ENDOWRIST SP
• Common Device Name: MARYLAND BIPOLAR FORCEPS
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 25224336
• Report Number: 2955842-2026-25694
• Device Sequence Number: 18641413
• Product Code: NAY
• UDI-Device Identifier: 00886874123461
• UDI-Public: (01)00886874123461(10)K10250926
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K241814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/19/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 430152-02
• Device Catalogue Number: 430152
• Device Lot Number: K10250926 0001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Sex: Unknown