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

Model Number	470249-09
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted mitral valve repair surgical procedure, the 8mm dual blade retractor instrument had a broken wire.The user completed the procedure with no further issue reported.No fragment fell inside the patient.No known impact or patient consequence was reported.Isi followed up with the initial reporter and obtained the following additional information: the instrument was being used to expose the valve when the issue occurred.There was no instrument collision during the procedure.The issue was related to the opening/closing of the grips.There was 1 cable visibly protruding from the distal end of the instrument.
Additional Manufacturer Narrative
Isi has received the instrument; however, failure analysis is still ongoing.Additional information is being gathered to determine the contribution of the device to the customer reported issue.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has received the 8mm dual blade retractor instrument associated with the customer-reported complaint.The instrument was analyzed and was found to have a broken pitch cable at the proximal clevis hole.The broken cable segment that contains the crimp was still installed in the clevis.The cable was fully broken.There was no evidence of discoloration or corrosion/contamination on the cables to indicate a reprocessing induced issue.The components surrounding the broken cable did not exhibit abnormal sharp edges or damage that would have contributed to the cable breaking.

• Brand Name: ENDOWRIST
• Common Device Name: DUAL BLADE RETRACTOR
• 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: 20058159
• Report Number: 2955842-2024-18625
• Device Sequence Number: 7784215
• Product Code: NAY
• UDI-Device Identifier: 00886874112403
• UDI-Public: (01)00886874112403(11)210722(10)N10210726
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K131861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2024

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: 470249-09
• Device Catalogue Number: 470249
• Device Lot Number: N10210726 0014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/06/2024
• Supplement Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 08/24/2024
• Supplement Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2021
• 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