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	10/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis and the complaint was confirmed.The dual blade retractor instrument was analyzed and found to have a broken distal pitch cable at the proximal clevis hub.The broken cable segment that contains the crimp was still installed in the clevis.The cable was fully broken.There were 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.Additional observation found unrelated to the customer reported complaint included: the instrument was found to have grip input disks #6 and #7 broken.
Event or Problem Description
It was reported that during a da vinci-assisted paraesophageal hiatal hernia surgical procedure the wire snapped on the dual blade retractor instrument.On 10/21/2024, intuitive surgical, inc.(isi) followed up with the customer and gathered the following information: there was a cable visibly protruding from the distal end of the instrument.The cables was one that controls the opening/closing of the jaws.No fragment fell into the patient.The instrument was inspected prior to use.No photographic images of the device or recording of the procedure is available for isi to review.

• 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: 20564361
• Report Number: 2955842-2024-21306
• Device Sequence Number: 7459619
• Product Code: NAY
• UDI-Device Identifier: 00886874112403
• UDI-Public: (01)00886874112403(11)230223(10)K10230226
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K131861
• 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): 10/08/2024

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: K10230226 0016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/08/2024
• Initial Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2023
• 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