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	12/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the cable of black diamond micro forceps instrument had snapped out.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the black diamond micro forceps instrument was inspected prior to use with no damage to be noted.Surgeon was suturing when issue occurred.The were no issues with opening / closing of the grips; left / right (yaw) motion of the grips or up/down (pitch) motion of wrist before the wires broke.There were no cables visibly protruding from the distal end of the instrument.No fragments fell into the patient.Instrument was returned for isi evaluation.No photographic images of the device(s) or a video recording of the procedure were available for isi review.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) requested that the black diamond micro forceps instrument 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
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the black diamond micro forceps instrument associated with this complaint and completed investigations.Failure analysis investigations replicated/confirmed the customer reported complaint that the "cable snapped out".The instrument was found to have a broken grip cable at the distal end.

• 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: 21146694
• Report Number: 2955842-2025-00425
• Device Sequence Number: 9117841
• Product Code: NAY
• UDI-Device Identifier: 00886874112229
• UDI-Public: (01)00886874112229(11)220922(10)K10220926
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2024

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: K10220926 0060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/19/2024
• Supplement Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/22/2022
• 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: ISIFA2024-09-C
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Sex: Unknown