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

Model Number	48645B-04
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	Bowel Perforation (2668)
Date of Event	08/28/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted gastric bypass surgical procedure, during stapling/cutting with a blue reload, the tissue bunched and created a tear in the bowel.As a result, the bowel was sutured.The procedure was completed and the patient¿s status was reported to be stable.On (b)(6) 2020, intuitive surgical, inc.(isi) received the following information from the site: it was reported that the stapler cut without firing the staples, and the surgeon sutured the hole in the bowel.It was confirmed that the surgeon did not use buttress material, and there is no video recording or photographic images for review.On (b)(6) 2020, isi received user facility medwatch report# 4900240000-2020-8096 regarding the event, which contained the following event description: da vinci 45 stapler for gastric bypass.Doctor fired a blue load staple and upon doing so, it cut the tissue however it failed to fire the staples leaving an open hole in the stomach.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the stapler 45 instrument associated with this complaint and completed investigations.Failure analysis investigations of the stapler instrument could not confirm or replicate the reported issue.The stapler instrument was installed on an in-house system where it passed the initialization test and moved intuitively with full range of motion in all directions.The instrument also passed the clamp/reload firing test and no errors were identified within the logs for the instrument.Isi also received the stapler 45 blue reload associated with this complaint and completed investigations.Failure analysis investigations of the reload did not replicate nor confirm the customer reported complaint.The reload was returned fired.The reload knife was seated at the distal end as expected.All of the reload pushers had been pushed up and all the staples had been fired.There was no cartridge damage.The reload was found to have a mechanical indentation on the blade, which was noted to not be related to the customer reported complaint.Isi has reviewed the system logs.Stapler 45 instrument (part# 470298-14, lot# t10200617-0044) fired five blue stapler 45 reloads.All firings were completed per the logs.There were no incomplete clamps by this instrument.No image or video clip for the reported event was submitted for review.This complaint is considered a reportable event due to the following conclusion: during a da vinci-assisted gastric bypass surgical procedure, during stapling/cutting with a blue reload, the tissue bunched and created a tear in the bowel.As a result, the bowel was sutured.Blank mdr fields: follow-up was attempted, but the missing patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.The expiration date for section is not applicable.Field is blank because the product is not implantable.Information for the blank fields in section is not available.Fields are not applicable.

• 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: 14823619
• Report Number: 2955842-2022-12455
• Device Sequence Number: 4613362
• Product Code: GDW
• UDI-Device Identifier: 10886874112875
• UDI-Public: (01)10886874112875(10)L90191028
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Notification,Other
• Type of Report: Initial
• Report Date (Section B): 09/04/2020

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: L90191028 0859
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/04/2020
• Initial Report FDA Received Date: 06/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2019
• 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: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: ISIFA2022-02-C
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 110 KG