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

Model Number	48360G-09
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the sureform 60 green reload to perform failure analysis.The reload was analyzed and found to have lodged staples.The deformed lodged staples were found at the knife groove.The reload was found to have undeployed pushers.Some of the pushers were undeployed with "b" shaped staples stuck in the staple sockets.Additionally, isi received the sureform 60 stapler instrument to perform failure analysis.The instrument was analyzed and found to have repeated clamping failures within a single install based on the log review.The instrument was functionally tested on an in-house system and achieved adequate compression on a test foam with a sureform 60 green reload installed.The instrument moved intuitively with full range of motion in all directions.The grips opened and closed properly.The instrument initialized, clamped, fired, and unclamped without any issues in both attempts.The complaint was confirmed by failure analysis.Blank mdr fields: the missing patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.The expiration date for section d4 is not applicable.Field d6 is blank because the product is not implantable.Information for the blank fields in section e1 is not available.Fields g5 and g7 are not applicable.
Event or Problem Description
It was reported that during a da vinci-assisted transcervical non-transthoracic esophagectomy surgical procedure, the customer noted that the sureform 60 stapler instrument compressed a lot with the 2nd sureform 60 green reload but finally triggered partially.After about half of the reload length, an error sounded and the instrument did not release completely.The blade remained extended and the reload could not be changed as a result.The customer replaced the sureform 60 stapler instrument with a back-up instrument of the same kind and completed the procedure with no reported injury.

• Brand Name: SUREFORM
• Common Device Name: STAPLER 60 RELOAD GREEN
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 20183860
• Report Number: 2955842-2024-19060
• Device Sequence Number: 8850829
• Product Code: GDW
• UDI-Device Identifier: 10886874113841
• UDI-Public: (01)10886874113841(10)NA
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K173721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 48360G-09
• Device Catalogue Number: 48360G
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/16/2024
• Initial Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2023
• 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: Prefer Not To Disclose