MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; DUAL BLADE RETRACTOR

Model Number	470249-09
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has not received the da vinci product with an alleged issue to perform failure analysis.A follow-up mdr will be submitted if the product is returned and evaluated and/or if additional information is received.
Event or Problem Description
It was reported that during a da vinci-assisted mitral valve repair surgical procedure, the customer stated that the dual blade retractor instrument installed on the universal surgical manipulator (usm3) was not moving as desired.An intuitive surgical, inc.(isi) technical support engineer (tse) suggested to reseat the sterile adapter (sa) but the customer was unable to do so.The procedure continued as planned with no report of patient injury.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the dual blade retractor instrument involved with this complaint and completed the device evaluation.Failure analysis investigation did not confirm the customer reported complaint.The reported issue with the instrument could not be replicated nor confirmed.Visual inspection was performed, and no grip misalignment was observed.No issues with manual articulation of the instrument's inputs were observed.The grip tips moved accordingly.The instrument was placed and driven on an in-house system.The instrument passed the recognition and engagement tests.The instrument moved intuitively with full range of motion in all directions.The grips/tips (for scissors) opened and closed properly.The instrument was fully functional.No product issue was identified.

• Brand Name: ENDOWRIST
• Common Device Name: DUAL BLADE RETRACTOR
• 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: 18853209
• Report Number: 2955842-2024-11982
• Device Sequence Number: 20639721
• Product Code: NAY
• UDI-Device Identifier: 00886874112403
• UDI-Public: (01)00886874112403(11)221006(10)K10221009
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K131861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2024

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: 470249-09
• Device Catalogue Number: 470249
• Device Lot Number: K10221009 0016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/12/2024
• Supplement Date Received by Manufacturer: 04/02/2024
• Initial Report FDA Received Date: 03/06/2024
• Supplement Report FDA Received Date: 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2022
• 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