MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; BLACK DIAMOND MICRO FORCEPS

Model Number	470033-09
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) requested that the black diamond micro forceps be returned for failure analysis investigation.Isi has not received the da vinci product with an alleged issue to perform failure analysis.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the wire of the black diamond micro forceps instrument was broken.The procedure was completed with no reported injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received a da vinci product involved with this complaint to perform failure analysis.The instrument was analyzed, and the reported failure was not confirmed.There were no frayed cables observed during visual inspection.The instrument articulated as expected during manual articulation.The instrument passed the recognition and engagement tests.The grips opened and closed properly.The instrument was fully functional.No product issue was identified with the instrument.Additionally, isi performed follow-up and obtained the following additional information regarding the reported event: the instrument was reportedly inspected prior to use, and no issue was noted.The issue was identified during tissue retraction.The failure was not related to the movement of the instrument.There were no cables protruding at the distal end of the instrument.No fragments fell inside the patient's anatomy.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: ENDOWRIST
• Common Device Name: BLACK DIAMOND MICRO 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: 21165323
• Report Number: 2955842-2025-00526
• Device Sequence Number: 9475674
• Product Code: NAY
• UDI-Device Identifier: 00886874112229
• UDI-Public: (01)00886874112229(11)221209(10)K10221212
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K131861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/25/2024

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: 470033-09
• Device Catalogue Number: 470033
• Device Lot Number: K10221212 0063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/25/2024
• Supplement Date Received by Manufacturer: 02/11/2025
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2022
• 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: Reuse
• 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