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

Model Number	470033-09
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted tubal reanastomosis surgical procedure, an uncontrolled motion was noted on the black diamond micro forceps instrument.The instrument did not work correctly.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) contacted the site and obtained additional information regarding this event: the issue did not occur with the surgeon's head inside the surgeon console's high-resolution stereo viewer.The issue occurred while the surgeon was attempting to manipulate instruments from the surgeon's console.The timing of instrument movement was appropriate.The action being taken and/or intended when the issue occurred was a change of instrument.There was no injury to the patient as a result of the event.There was no injury to the patient as a result of the event.No further information is available.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has issued a return material authorization (rma) to have the intuitive device returned.However, isi has not received the product involved with the alleged issue to perform failure analysis.Additional information is being gathered to determine the contribution of the device to the customer reported issue.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The black diamond micro forceps instrument was analyzed and found to have a severely bent grip tip.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
Additional information, based on further failure analysis investigation was obtained: the reported complaint could not be replicated, nor confirmed, during the failure analysis investigation, as the instrument was recognized by the test system and successfully passed all functional tests.The instrument was fully functional.No product issue was found.Based on the investigation results, customer reported issues may be due to other factors unrelated to the product.

• 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: 19725658
• Report Number: 2955842-2024-16868
• Device Sequence Number: 8328391
• Product Code: NAY
• UDI-Device Identifier: 00886874112229
• UDI-Public: (01)00886874112229(11)210617(10)N10210621
• 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: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/13/2024

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: N10210621 0008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/13/2024
• Supplement Date Received by Manufacturer: 08/14/2024; 09/03/2024
• Initial Report FDA Received Date: 07/11/2024
• Supplement Report FDA Received Date: 08/29/2024; 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2021
• 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: Female