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

Model Number	430152-02
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has not received the da vinci product with an alleged issue to perform failure analysis.A follow-up mdr will be submitted if the product is returned and evaluated and/or if additional information is received.The image showed an sp maryland bipolar forceps instrument with a broken molded insulator and there could be missing pieces of the plastic molded insulator:.
Event or Problem Description
It was reported that during da vinci-assisted pediatric pyeloplasty surgical procedure, sp maryland bipolar forceps instrument had misaligned jaws.The procedure was completed with no reported injury.
Additional Manufacturer Narrative
Intuitive surgical inc.(isi) received the sp maryland bipolar forceps instrument for failure analysis investigation.The instrument was analyzed and found to have a broken molded insulator.Visual inspection was performed and the instrument was observed to have a broken lower molded insulator.The broken piece measures approximately 1.1mm x 9.3mm and was returned with the instrument.However, a small, detached fragment from the lower molded insulator was missing.The detached fragment measures approximately 0.32mm x 0.72mm.The broken lower molded insulator is the likely cause of the detached fragment.The grip base for the grip with the cracked molded insulator does not appeared to be bent.There was no external damage to the shaft, housing, and snake wrist cables.Each input disk was manually articulated and responded accordingly.The release buttons were functional.The complaint was confirmed by failure analysis.Additional observation(s) related to the customer reported complaint: the instrument was found to have a detached fragment.The instrument w observed to have detached lower molded insulator from the grip base.The detached fragment measures approximately 1.1mm x 9.3mm and was returned with the instrument.However, a small, detached fragment from the lower molded insulator was missing.The small fragment measures approximately 0.32mm x 0.72mm and was not returned with the instrument.The detached fragments are likely caused by the broken lower molded insulator.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.
Event or Problem Description
Refer to h11 for follow-up information.

• 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: 24773091
• Report Number: 2955842-2026-20344
• Device Sequence Number: 9925627
• Product Code: NAY
• UDI-Device Identifier: 00886874123461
• UDI-Public: (01)00886874123461(11)250408(10)K10250408
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K241814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/21/2026

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: K10250408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/23/2026
• Supplement Date Received by Manufacturer: 04/09/2026; 04/28/2026
• Initial Report FDA Received Date: 04/03/2026
• Supplement Report FDA Received Date: 05/04/2026; 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2025
• 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