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

Model Number	470545-02
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the curved-tip stapler 45 instrument involved with this complaint and completed the device evaluation.Failure analysis investigations replicated/confirmed the customer reported complaint of "instrument didn't engage with robotic arm." failure analysis found the initialization failure to be related to the customer reported complaint.The instrument was found to have failed during initialization during in-house testing.There were additional observations not reported by the site and related to the primary failure.The instrument was found to have a shifting failure based on a log review.A review of the log showed the shifting failure occurred during initialization.The instrument was found to have the shift input disk to be broken.Failure analysis investigations did not replicate nor confirm the customer reported complaint of "scrub tech wasn't able to open jaws on the stapler to replace the reload." the instrument jaws were manually opened and closed without issue.There was no damage observed on the distal end of the instrument.
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary wedge resection surgical procedure, a curved-tip stapler instrument didn't engage with the system arm.While troubleshooting, the scrub tech was not able to open jaws on the stapler to replace the reload.They had to open a new instrument due to the issue.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter on 3-aug-2021 and obtained the following additional information: she stated the stapler was not stuck on the patient tissue and the stapler release kit (srk) was never used.The stapler was not engaging.After this, the tech was able to open the jaws to remove the reload.They used a back up stapler to continue with the surgery.

• Brand Name: ENDOWRIST
• Common Device Name: CURVED TIP 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: 17015910
• Report Number: 2955842-2023-15029
• Device Sequence Number: 20565055
• Product Code: NAY
• UDI-Device Identifier: 00886874113806
• UDI-Public: (01)00886874113806(10)T10171030
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K170879
• 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): 07/13/2021

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: 470545-02
• Device Catalogue Number: 470545
• Device Lot Number: T10171030 0013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/13/2021
• Initial Report FDA Received Date: 05/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2017
• 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