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

Model Number	48645B-04
Medical Device Problem Codes	Misfire (2532); Failure to Cut (2587)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	05/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the stapler 45 instrument blue reload instrument involved with this complaint and completed the device evaluation.Failure analysis investigation (fa) confirmed the customer reported complaint.The reload was found to have the knife exposed within the knife track.Log review showed that this reload was fired partially.No error message occurred because the shuttle assembly of the reload broke internally exposing the knife midway through the garage track but the staples still managed to all deploy.Fa found an additional issue that was not reported by the customer.The knife of the reload was found with an indentation to the blade edge.The stapler cover was removed to access the internal components of the reload.Additional observation not reported was body cartridge damage appeared under microscopic inspection.Any potential fragments would have been retained inside the cartridge and shuttle cover.Cartridge body damage was observed to the outside of the reload where the exposed blade resided.Material appeared to be lifted up off the body, but no material appeared to be missing.
Event or Problem Description
It was reported that during a da vinci-assisted sigmoid colectomy surgical procedure, the customer fired a stapler 45 instrument with a blue reload and staples fell into the patient.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: it was confirmed that the fragment was retrieved during the same procedure.The fragment was retrieved with a laparoscopic forceps.There was no additional surgical procedure required to remove the fragment.The surgeon believes that there was something wrong with the reloads.The issue occurred at the second firing while stapling the colon.There was no injury to the patient.The customer did not perform post-operative tests to check for a remaining fragment.There was no collision with any other instrument or hard material.Upon final removal, the wrist was straightened, and no resistance felt.The cannula and instrument was inspected after the procedure, and no damage was noted.Isi followed up with the initial reporter and the following additional information was obtained: the fragment fall into patient was referring to a staple.They remove it with a laparoscopic forceps.Regarding the report of "stapling and cutting issue" with the stapler 45 instrument: per additional information communicated by the isi clinical sales representative (csr), it was clarified that the surgeon stated that the stapler fired staples but the knife did not cut the tissue when using a blue reload.They had to remove the stapler and used the scissors for cutting.Further information provided by the hospital contact indicated that the surgeon successfully completed the staple line using a new reload.It was confirmed there was no leakage.There was no report of patient harm, injury or adverse outcome due to the issue and the patient was doing fine.

• 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: 17015648
• Report Number: 2955842-2023-14772
• Device Sequence Number: 18031243
• Product Code: GDW
• UDI-Device Identifier: 10886874112875
• UDI-Public: (01)10886874112875(10)L92190422
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K140553
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/11/2020

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: L92190422 0647
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/11/2020
• Initial Report FDA Received Date: 05/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2019
• 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