MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; STAPLER 45

Model Number	470298-11
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The stapler 45 instrument was analyzed, and the complaint was not confirmed by failure analysis.Failure analysis found the instrument was active with 5 uses remaining.No product issue was identified.The complaint was confirmed by failure analysis.Additional observations not reported by site: the instrument was 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 instrument was found to have the main tube broken.No material was found missing.
Event or Problem Description
It was reported that during central processing, the cable was broken on the stapler 45 instrument.The procedure was completed with no report of patient injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the technicians were trained to do a quick look before insertion to look for anything out of the ordinary.Everything on the instrument appeared to be intact.It wasn¿t until the instrument was actually in the initial motions that the cable was discovered because the instrument would not move properly when tested by the surgeon (they always test the motion after initial insertion to be sure it is all working, which this was not).The staff removed the instrument and discovered the cable was damaged.The instrument never worked.After initial insertion, it did not motion properly so it was removed and inspected, discovering the cable.The instrument did not collide with any other instruments during the procedure.No fragments fell inside the patient's anatomy.The instrument was sent to isi for analysis.No photos or videos are available for review.
Additional Manufacturer Narrative
The endowrist stapler 45 instrument has been evaluated by the failure analysis (fa) team.Fa was able to reproduce and confirm the reported complaint.The instrument was found to have a broken (disposable loading unit) dlu wire at the distal end.The instrument failed the electrical continuity test.A review of the logs shows no errors.
Event or Problem Description
Refer to h10/h11 for follow-up information.

• Brand Name: ENDOWRIST
• Common Device Name: STAPLER 45
• 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: 18490517
• Report Number: 2955842-2023-22050
• Device Sequence Number: 6991385
• Product Code: NAY
• UDI-Device Identifier: 00886874112427
• UDI-Public: (01)00886874112427(10)T10180622
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K140553
• 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,Followup
• Report Date (Section B): 12/21/2023

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: 470298-11
• Device Catalogue Number: 470298
• Device Lot Number: T10180622 0068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/21/2023
• Supplement Date Received by Manufacturer: 01/08/2024
• Initial Report FDA Received Date: 01/11/2024
• Supplement Report FDA Received Date: 02/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2018
• 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