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

Model Number	470381-12
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The instrument was returned with the reducer and seal still attached.There was no damage to the reducer or the seal.Isi received a video clip related to the alleged complaint and the following additional information was provided: a cannula with a reducer was visible.There was a thin metal ring protruding from inside the cannula, which is then pushed out by the insertion of an instrument.As confirmed by failure analysis, this appears to be a shaving from the reducer left over from the machining process.
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary lobectomy surgical procedure, the collar of the reducer was cracked.The customer used a backup reducer to continue with the planned procedure.No fragment fell inside the patient.No known impact or patient consequence was reported.

• Brand Name: ENDOWRIST
• Common Device Name: REDUCER
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 19068912
• Report Number: 2955842-2024-13197
• Device Sequence Number: 6825982
• Product Code: NAY
• UDI-Device Identifier: 10886874112585
• UDI-Public: (01)10886874112585(10)L82230824
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K162411
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/12/2024

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: L82230824
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/12/2024
• Initial Report FDA Received Date: 04/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2023
• 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: Unknown
• 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