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

Model Number	470298-14
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive has received the part associated with this complaint and completed investigations.Failure analysis investigations confirmed but did not replicate the customer reported complaint "stapler can no longer be opened, is jammed, emergency tool had to be used." failure analysis found the primary failure of unclamp failure to be related to the customer reported complaint.The instrument was found to have an unclamp failure(s) based on log review but was not replicated during in-house testing.Logs show error code 22030, indicating a stapler 45mm (serial# (b)(6)).Failed in its operation on usm4 with a failure mode: unclamping failure / general failure.The stapler was tested in-house and the instrument initialize clamped, fired, and unclamped without any issues.The instrument moved intuitively with a full range of motion in all directions.The grips opened and closed properly.No errors occurred during testing.Upon visual inspection, there was no damage at the distal wrist.Additional observations not reported by site: the housing was removed for inspection and the instrument was found to have a broken lever.The broken piece, measuring approximately 0.120" x 0.206" in size was found within the housing.No missing material was observed.The instrument was found to have a broken chassis.The broken piece was returned, measuring roughly 0.118¿ x 0.206¿ in size, and was found within the housing.No missing material was observed.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the stapler 45 instrument was jammed and could no longer be opened.The stapler release kit was used to remove the instrument.The procedure was completed with no reported injury.

• 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: 17093856
• Report Number: 2955842-2023-16102
• Device Sequence Number: 13936136
• Product Code: NAY
• UDI-Device Identifier: 00886874112427
• UDI-Public: (01)00886874112427(10)T10210826
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K140553
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/07/2022

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: 470298-14
• Device Catalogue Number: 470298
• Device Lot Number: T10210826 0012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/07/2022
• Initial Report FDA Received Date: 06/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2021
• 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: Initial
• 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