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

Model Number	48445G-04
Medical Device Problem Code	Misfire (2532)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary wedge resection procedure, the endowrist stapler 45 instrument misfired when a green stapler 45 reload was fired.As a result, the surgeon elected to convert the procedure to open surgery.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.
Additional Manufacturer Narrative
Based on the current information provided, the cause of the customer reported failure mode cannot be determined.Isi has requested for return of the green stapler 45 reload.However, the product has not been returned for evaluation.A follow-up mdr will be submitted when failure analysis has completed their investigation.This complaint is being reported due to the following conclusion: the customer converted to open surgery after the start of the da vinci-assisted surgical procedure due to a stapler misfire.

• Brand Name: ENDOWRIST
• Common Device Name: STAPLER 45 RELOAD
• 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: 16988961
• Report Number: 2955842-2023-14508
• Device Sequence Number: 20546331
• Product Code: GDW
• UDI-Device Identifier: 10886874112820
• UDI-Public: (01)10886874112820(10)M90220522
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 48445G-04
• Device Catalogue Number: 48445G
• Device Lot Number: M90220522
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2023
• Initial Report FDA Received Date: 05/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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 Age: 64 YR
• Patient Sex: Female