MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; REDUCER

Model Number	470381-12
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the reducer to perform failure analysis (fa).The reducer was found to be broken at the distal end of the shaft.As a result, the reducers metal tip became dislodged.There was no material missing.Broken piece of the shaft was captured inside of the tip.
Event or Problem Description
The reducer was an incidental return included with rma 302126000010.There was no reported issue against the reducer or reported patient injury.Intuitive surgical, inc.(isi) followed up with the initial reporter, but no additional information was obtained.

• Brand Name: ENDOWRIST
• Common Device Name: REDUCER
• 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: 20829048
• Report Number: 2955842-2024-22664
• Device Sequence Number: 4069886
• Product Code: NAY
• UDI-Device Identifier: 10886874112585
• UDI-Public: (01)10886874112585(10)NA
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K162411
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/06/2024

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: 470381-12
• Device Catalogue Number: 470381
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/06/2024
• Initial Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2022
• 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: Prefer Not To Disclose