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

Model Number	470171-09
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has received the micro bipolar forceps instrument involved with this complaint to perform failure analysis (fa) testing and the fa is still in progress.
Event or Problem Description
It was reported that the micro bipolar forceps instrument had a seam in plastic at distal tip opening.Blood or rust inside.There was no reported injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The micro bipolar forceps instrument was analyzed and could not reproduce expected condition to be related to the customer reported complaint.Visual inspection displayed no signs of physical damage.No missing or broken components observed.The instrument was returned with a report complaint that does not affect functionality and is a part of the instruments design.The instrument is in its expected condition.The product is considered conforming in its current state.The complaint was not confirmed by failure analysis.The probable root cause cannot be determined.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: ENDOWRIST
• Common Device Name: MICRO 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: 21757536
• Report Number: 2955842-2025-13013
• Device Sequence Number: 15519773
• Product Code: NAY
• UDI-Device Identifier: 00886874112274
• UDI-Public: (01)00886874112274(10)S10140703
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K131861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2025

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: 470171-09
• Device Catalogue Number: 470171
• Device Lot Number: S10140703 0009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/11/2025
• Supplement Date Received by Manufacturer: 04/17/2025
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2014
• 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