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

Model Number	430010-62
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The maryland bipolar forceps instrument was analyzed and found to have bent grip tips.A visual inspection revealed that the upper grip tip was misaligned from its original position.The offset at the tips was approximately 1.23mm, and the grips were found not to be cracked.The offset of the grip tip is likely to cause the dislodged molded insulator.There was no damage to the main tube, snake wrist, or housing.Each input disk was manually articulated, and no issues were found.The release buttons were functional.Additionally, the instrument was found to have a cracked molded insulator on the jaw.Upon visual inspection, the upper molded insulator was found to have a crack that measured approximately 1.6mm from the grip tips.The cracked upper molded insulator is likely caused by the misaligned grip tips.Additionally, the instrument was found to have mechanical indentations.A visual inspection was performed, and mechanical indentations were observed on the lower grip tips.The instrument was found to have thermal damage on the molded insulator.During visual inspection, black and brown substances were observed on the upper molded insulator, indicating material degradation due to current leakage.The complaint was confirmed by failure analysis.The probable root cause of bent grips is attributed to damage during use, as moderate misalignment of grip tips can be due to grasping either hard tissue/objects or collisions with other instruments.The probable root cause 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 probable root cause of thermal damage is attributed to carbonized tissue on the grips of this bipolar instrument creating a conductive path during use.The probable root cause of nicks and gouges on the instrument grip tips is attributed to damage during use or reprocessing.Damage can result from mechanical impact, such as accidental drops of the instrument, inadvertent collisions with other instruments or hard surfaces, or abrasive instrument cleaning.
Event or Problem Description
It was reported that during central processing, the maryland bipolar forceps instrument was broken and was not aligning up.No known impact or patient consequence was reported.

• 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: 25262660
• Report Number: 2955842-2026-26126
• Device Sequence Number: 5432555
• Product Code: NAY
• UDI-Device Identifier: 00886874114322
• UDI-Public: (01)00886874114322(11)240912(10)K10240912
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 05/22/2026

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: 430010-62
• Device Catalogue Number: 430010
• Device Lot Number: K10240912 0003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/01/2026
• Initial Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2024
• 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