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

Model Number	430010-57
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during central processing , the jaws of 6mm maryland bipolar forceps instrument broke.There were no reports of patient involvement or patient injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the 6mm maryland bipolar forceps instrument to perform failure analysis.Failure analysis investigations confirmed the customer reported complaint.The instrument was analyzed and it was found to have a broken molded insulator on the upper jaw.The broken molded insulator likely caused the grip tip to be fully detached.The instrument was found to have a detached fragment likely caused by the broken over molded insulator.The entire upper grip tip was detached and was not returned with the instrument.The grip base for the grip with the cracked molded insulator was not bent.The input disks were manually articulated with no issues.The grip knob was able to rotate, allowing the grips to open/close without any issues.The bipolar instrument's conductor wire was found to be broken on the side with the upper jaw.The broken wire was likely caused by the broken over molded insulator.The wire was sticking out and would have failed electrical continuity.Additional observation(s) : the instrument was found to have corroded pulley cables.The probable root cause of broken components (molded insulator and grip tip) is attributed to damage during use, which may result from applying excess force on the instrument tip during handling, insertion, usage (overloading), or removal.The missing patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.The expiration date for section d4 is not applicable.Field d6 is blank because the product is not implantable.Field e4 is blank because it is unknown if the initial reporter submitted a report to the fda.Fields g5 and g7 are not applicable.Field h10 is blank as there are no related report numbers.

• 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: 23701743
• Report Number: 2955842-2025-47197
• Device Sequence Number: 16125196
• Product Code: NAY
• UDI-Device Identifier: 00886874114322
• UDI-Public: (01)00886874114322(10)U10240208
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K182371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/02/2025

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: 430010-57
• Device Catalogue Number: 430010
• Device Lot Number: U10240208 0024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/12/2025
• Initial Report FDA Received Date: 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2024
• 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