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

Model Number	470298-12
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the endowrist stapler 45 involved with this complaint and completed the device evaluation.Failure analysis (fa) investigation confirmed but not replicated the customer reported complaint of "stapler would not fire and would not open." a review of the stapler log showed one shifting failure with error code 22030.A review of the stapler log also showed one incomplete clamp, but no firing failures.The logs confirmed that the grip release tool was detected, as well as an instrument manual grip release misuse.The instrument was placed on the in-house system, and it failed the initialization test.An unjamming tool was used on the instrument, and it passed the initialization when put back on the system.The instrument clamped, fired, and unclamped successfully.The instrument was found to have a frayed grip cable.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the endowrist stapler 45 instrument clamped on tissue, but it would not fire and the jaws did not open.The customer used a stapler release kit (srk) to open the stapler 45 instrument jaws and remove it from tissue.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) made multiple follow-up attempts to obtain additional information.However, no further details have been received as of the date of this report.This complaint will be classified based on the provided information at this time.

• 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: 17015899
• Report Number: 2955842-2023-15017
• Device Sequence Number: 7555610
• Product Code: NAY
• UDI-Device Identifier: 00886874112427
• UDI-Public: (01)00886874112427(10)T11190111
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Report Date (Section B): 06/06/2020

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: 470298-12
• Device Catalogue Number: 470298
• Device Lot Number: T11190111 0038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/06/2020
• Initial Report FDA Received Date: 05/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2019
• 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