MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SUREFORM; STAPLER 60 RELOAD BLACK

Model Number	48360T-08
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	04/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted sleeve gastrectomy surgical procedure, the surgeon fired a black sureform 60 reload with a sureform 60 stapler instrument and on the outer row, one staple was found to be sticking straight up and did not curl back.The surgeon cut the staple out and oversewed that area.No further clinical information was provided.Isi made multiple follow-up attempts to obtain additional information from the physician.However, no further details have been received as of the date of this report.
Additional Manufacturer Narrative
Based on the current information provided, the root cause of the customer reported failure mode cannot be determined or is unknown.Isi has requested for return of the black surefrom 60 reload for failure analysis investigation but at this time the stapler reload has not been returned.If additional information is received, a follow-up mdr will be submitted.Stapler log review was completed, and the following information was provided: the sureform 60 stapler instrument (part #480460-09; lot #l92220216-0320) was used for 6 firing events with the following reload color sequence: black, green, blue, blue, blue, and white.All firings were complete/successful.There are no errors in the logs related to the reported problem.No image or video clip for the reported event was submitted for review.This complaint is being reported due to the following conclusion: during a da vinci-assisted sleeve gastrectomy procedure, a staple was not properly formed after the surgeon fired a black sureform 60 reload with a sureform 60 stapler instrument.As a result, the surgeon cut out the staple and oversew that area.It is unclear if there was any unapproximated tissue.The cause of the customer reported failure mode is unknown.

• Brand Name: SUREFORM
• Common Device Name: STAPLER 60 RELOAD BLACK
• 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: 14515778
• Report Number: 2955842-2022-11809
• Device Sequence Number: 6552098
• Product Code: GDW
• UDI-Device Identifier: 10886874113858
• UDI-Public: (01)10886874113858(10)T90211001
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K173721
• 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: Notification,Other
• Type of Report: Initial
• Report Date (Section B): 04/26/2022

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: 48360T-08
• Device Catalogue Number: 48360T
• Device Lot Number: T90211001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/26/2022
• Initial Report FDA Received Date: 05/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2021
• 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: ISIFA2022-02-C
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Sex: Unknown