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

Model Number	478093-03
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has issued a return material authorization (rma) to have the device returned.However, isi has not received the instrument 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.
Event or Problem Description
It was reported that the fenestrated bipolar forceps instrument plastic cover was left.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) received the following additional information via follow up: the issue that occurred was that during central processing it was discovered that the plastic tip of the instrument had broken off.There were no reports of patient involvement nor injury when the issue was found.
Additional Manufacturer Narrative
Intuitive surgical inc.(isi) received the 8mm fenestrated bipolar forceps instrument for failure analysis investigation.The instrument was analyzed and was no physical damage.There was no problem detected.The instrument was fully functional.No product issue was found.The reported complaint could not be replicated, nor confirmed, during the failure analysis investigation.The instrument was fully functional no product issue was found.Device history record (dhr) review-dhr review for the device(s) involved with the reported event has been completed.No non-conformances were identified to be related to this complaint.The probable root cause cannot be determined based on the information provided and failure analysis results.No product issue was identified.The reported event was not confirmed as failure analysis found that there was no physical damage.There was no problem detected.The instrument was fully functional.No product issue was found.The instrument was visually inspected and evaluated for its mechanical and/or electrical characteristics.The failure analysis investigations and in-house testing of the returned product revealed no issues related to the customer reported event.

• Brand Name: SINGLE-SITE
• Common Device Name: FENESTRATED BIPOLAR 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: 21600106
• Report Number: 2955842-2025-08123
• Device Sequence Number: 8266496
• Product Code: NAY
• UDI-Device Identifier: 10886874113735
• UDI-Public: (01)10886874113735(10)NA
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K130726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2025

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: 478093-03
• Device Catalogue Number: 478093
• Device Lot Number: NA NA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/16/2025
• Supplement Date Received by Manufacturer: 04/10/2025
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2021
• 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
• Patient Sex: Unknown