MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SUREFORM; 8MM STAPLER RELOAD

Model Number	48230M-02
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has received the part associated with this complaint and completed investigations.Failure analysis investigations replicated and confirmed the customer reported complaint the grey reload was difficult to install.Failure analysis found the primary failure of cartridge damage to be related to the customer reported complaint.The reload did not show any obvious physical or cosmetic damage.However, when attempting to install the reload onto the in-house sureform 30 stapler, the reload revealed the cartridge was damaged at the tail end or proximal end near the driver.The edge piece of the reload holding the driver was cracked and began to break during installation onto the stapler.The reload was unable to be fired on an in-house system.The root cause of this failure is attributed to user mishandling, commonly caused by the improper installation onto the instrument.For clarification, failure analysis found the primary failure of broken reload to be related to the customer reported complaint.In addition to there being a user related aspect as a common cause of breakage, for the 8mm sureform 30 reload, the design may also be a contributing factor, as the design includes a tail and other features that need to be properly aligned with respect to the channel.Verification of the event details via system logs cannot be performed since fa confirmed the reload was unopened and not used during a procedure.No image or video clip for the reported event was submitted for review.This complaint is being reported due to the following conclusion: failure analysis identified that a component of the reload experienced a break.While there was no report of harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.
Event or Problem Description
It was reported that during a da vinci-assisted thoracic procedure, the grey reload was difficult to install.The tips were flimsy and would bend during installation.The procedure was completed with no reported injury.

• Brand Name: SUREFORM
• Common Device Name: 8MM STAPLER RELOAD
• 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: 15721245
• Report Number: 2955842-2022-15058
• Device Sequence Number: 19565875
• Product Code: GDW
• UDI-Device Identifier: 10886874121938
• UDI-Public: (01)10886874121938(10)U90220518
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K211997
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/04/2022

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: 48230M-02
• Device Catalogue Number: 48230M
• Device Lot Number: U90220518
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2022
• Initial Report FDA Received Date: 11/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2022
• 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: ISIFA2022-10-R
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 85 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White