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

Model Number	470298-14
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the claim against the product, an investigation was completed to determine the cause of this reported event.(b)(4) did receive a da vinci stapler 45 instrument to perform failure analysis.The stapler 45 instrument was analyzed and upon visual inspection, the chassis on the back end found one of the gold pogo pins to be broken off.The pin was completely broken and was not returned with the instrument.The back end of the instrument does not come into contact with the patient, therefore, there were no potential fragments.Damaged pogo pins can influence the failure of reload recognition.However, no reload recognition failures were found in the logs or occurred during in-house testing.The root cause for the broken pogo pins is not established and will be transferred to engineering for further review.Additional observation(s) not reported by site: based on a review of the logs, the instrument had several shifting failures.However, the shifting failures were not replicated during in-house testing.The instrument was installed onto an in-house system and passed initialization.The instrument moved intuitively with a full range of motion in all directions.The jaws opened and closed properly.The stapler was fired using a blue 45 reload.
Event or Problem Description
It was reported central processing, the stapler 45 instrument was noted with a gold pin broken off on the casing.There was no report of patient involvement or 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: 17313040
• Report Number: 2955842-2023-16991
• Device Sequence Number: 6225856
• Product Code: NAY
• UDI-Device Identifier: 00886874112427
• UDI-Public: (01)00886874112427(10)T10201109
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 06/13/2023

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: 470298-14
• Device Catalogue Number: 470298
• Device Lot Number: T10201109 0001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/13/2023
• Initial Report FDA Received Date: 07/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2020
• 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