MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; POTTS SCISSORS

Model Number	470001-09
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the da vinci product to perform failure analysis.The potts scissors instrument was analyzed and found to the instrument was found to have one (1) severely bent grip, causing misalignment of the grip-tips.There was a 0.051" offset at the tips.The grips were not found to have cracking damage.The instrument was found to have a broken grip at the grip tip.A piece approximately 0.020" x 0.051" was found to be broken off.The broken piece was not returned with the instrument.Further inspection of the returned instrument found no additional damage or abnormalities.
Event or Problem Description
It was reported that the customer experienced an unknown issue with the potts scissors instrument.The customer reported event has no report of patient injury.Intuitive surgical, inc.(isi) followed up with the customer and gathered the following information: there was no report of fragments falling from the device while used within a patient.

• Brand Name: ENDOWRIST
• Common Device Name: POTTS SCISSORS
• 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: 20731258
• Report Number: 2955842-2024-22151
• Device Sequence Number: 18218731
• Product Code: NAY
• UDI-Device Identifier: 00886874112120
• UDI-Public: (01)00886874112120(11)230810(10)K10230810(91)0007
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/29/2024

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: 470001-09
• Device Catalogue Number: 470001
• Device Lot Number: K10230810 0008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2024
• Initial Report FDA Received Date: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2023
• 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: Prefer Not To Disclose