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

Model Number	470033-09
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has received the 8mm black diamon micro forceps instrument; however, failure analysis investigations are under progress.Additional information is being gathered to determine the contribution of the device to the customer reported issue.
Event or Problem Description
It was reported that after a da vinci-assisted surgical procedure, the 8mm black diamon micro forceps instrument was observed to have a broken cable.The procedure was completed with no reported injury.There were no reports of fragment(s) falling into the patient.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the 8mm black diamond micro forceps instrument to perform failure analysis.Failure analysis investigations did not confirm the customer reported complaint.The instrument was manually articulated and it did not have any issues with cables.Additional observation(s) : the instrument had one bent grip, causing misalignment of the grips.There was a 0.21 mm offset at the tips.The grips did not show cracking damage.Based on additional information, it has been determined that the instrument involved with this complaint does not meet the criteria for isifa2024-09-c as previously listed in section h9.

• 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: 22515137
• Report Number: 2955842-2025-30165
• Device Sequence Number: 15441586
• Product Code: NAY
• UDI-Device Identifier: 00886874112229
• UDI-Public: (01)00886874112229(11)220922(10)K10220926
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K131861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other,Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2025

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 0176
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/24/2025
• Supplement Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 07/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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