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

Model Number	48645B-04
Medical Device Problem Code	Misfire (2532)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product related to the reported event has been returned for evaluation.Therefore, there is no failure analysis of the product.
Event or Problem Description
It was reported that during a da vinci-assisted sigmoid colectomy surgical procedure, the stapler 45 instrument misfired with two different blue reloads.The customer noted an exposed blade error message and staples fell inside the patient.The staples were retrieved during the same procedure.The customer used a third party laparoscopic stapler to continue and the procedure was completed with no injury to the patient.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained additional information: the instrument and accessories were inspected prior to use with no damage noted.The procedure was a da vinci-assisted low anterior resection surgical procedure.The reported issue happened during a second fire on the bowel tissue with the stapler 45 instrument.The tissue was not exposed to any radiation/chemotherapy and it was not calcified.Prior to the stapler fire, the surgeon experienced clamping issue and encountered obstructions between the instrument jaws.The surgeon did not use buttress material.The surgeon also noted malformed staples.There was no excessive bleeding or tissue damage.The or staff discarded all reloads that were used during the procedure so they are not available for return.

• Brand Name: ENDOWRIST
• Common Device Name: STAPLER 45 RELOAD BLUE
• 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: 16927522
• Report Number: 2955842-2023-13420
• Device Sequence Number: 6720435
• Product Code: GDW
• UDI-Device Identifier: 10886874112875
• UDI-Public: (01)10886874112875(10)L90190729
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/05/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 48645B-04
• Device Catalogue Number: 48645B
• Device Lot Number: L90190729 0948
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/05/2021
• Initial Report FDA Received Date: 05/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2019
• 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 Sex: Unknown