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

Model Number	470007-05
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received a da vinci product to perform failure analysis.The round tip scissors instrument was analyzed and found to have a broken distal pitch cable at the distal end.The broken cable segment that contains the crimp was still installed in the clevis.The complaint regarding cable issues was confirmed by failure analysis.
Event or Problem Description
It was reported that prior to starting a procedure the round tip scissors instrument had broken cables.The procedure was completed with no reported injury.Intuitive surgical inc.(isi) followed up with the customer and confirmed that the issue was noticed during inspection, prior to the case, and there was no report of fragments falling from the device while used within a patient so there was no fragment from the broken cables that fell inside a patient.

• Brand Name: ENDOWRIST
• Common Device Name: ROUND TIP SCISSORS
• 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: 17340535
• Report Number: 2955842-2023-17126
• Device Sequence Number: 6524352
• Product Code: NAY
• UDI-Device Identifier: 00886874112168
• UDI-Public: (01)00886874112168(10)N10180924
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K150284
• 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
• Report Date (Section B): 06/21/2023

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: 470007-05
• Device Catalogue Number: 470007
• Device Lot Number: N10180924 0023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/21/2023
• Initial Report FDA Received Date: 07/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2018
• 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