MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SINGLE-SITE; BIPOLAR MARYLAND

Model Number	478080-03
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The bipolar marland instrument has not been received for failure analysis evaluation.
Event or Problem Description
It was reported that during a da vinci-assisted benign hysterectomy surgical procedure, bipolar maryland instrument got stuck against uterus.The black sheath at the instrument¿s tip was folded onto itself.The instrument was stuck, and trocar/instrument had to be removed by a surgical assistant.A piece had also fallen off the arm and was found later.Sterile adaptor (sa) had to be cut off from the sheath of the arm to free it.The procedure was completed.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: during a robotic surgical procedure, a fragment from an instrument fell inside the patient while grasping tissue.The instrument had been checked before use and appeared normal, with no reported damage or unusual function throughout its use.There was no collision or resistance noted during instrument removal, and no injury to the uterus or patient occurred.All fragments were retrieved using another instrument and confirmed by the doctor, and no further procedures or imaging were needed.The surgery was completed robotically.The instrument has been shipped for evaluation, but the retrieved fragment was not returned.There were no photos or videos available, and no post-operative complications have been reported.The cause of the instrument breakage is unknown.
Additional Manufacturer Narrative
Updated fields: d9, h2, h3, h6, and h11 device evaluation: intuitive surgical, inc.(isi) the bipolar maryland instrument to perform failure analysis.The instrument was analyzed and found to have torn insulation on the main tube.The torn material measured approximately 27.01mm x 5.85mm in size.The torn material was not returned.Additionally, the instrument was found to have a broken distal clevis at the ears of the clevis.The broken piece measuring roughly 8.19mm x4.48mm in size was not returned.The instrument was also found to have one bent grip, causing them to be misaligned.The offset at the tips was 1.14mm.The grips were not found to be cracked.The grip tip was bent due to the distal clevis breakage.The instrument was found to have the translucent cover on the proximal clevis torn and missing.The broken pieces, measuring roughly 9.16mm x 5.63mm in size were not returned.Components adjacent to this broken proximal cover showed damage.The distal clevis was broken and some pieces were missing.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: SINGLE-SITE
• Common Device Name: BIPOLAR MARYLAND
• 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: 23510695
• Report Number: 2955842-2025-44334
• Device Sequence Number: 18558637
• Product Code: NAY
• UDI-Device Identifier: 00886874113707
• UDI-Public: (01)00886874113707(17)260531(10)K10240516
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K152448
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 478080-03
• Device Catalogue Number: 478080
• Device Lot Number: K10240516 0010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/17/2025
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Weight: 76 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White