MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. CONTOUR CURVED CUTTER STAPLER; STAPLE, IMPLANTABLE

Model Number	CS40B
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a low anterior resection procedure that the surgeon struggled with how to use and how to fire the device and that it didn¿t fire ¿correctly¿, and patient received a colostomy.
Additional Manufacturer Narrative
(b)(4).Batch # 341a52 additional information was requested, and the following was received: what were the indications for surgery? was the colostomy pre-planned as part of the initial surgery? did the patient receive any preoperative chemotherapy or radiation? what is the users experience with the cs40b device? please explain what is meant by, ¿surgeon struggled with how to use the device?¿ please explain what is meant by, ¿device did not fire correctly?¿ has the surgeon received any additional in-servicing since this incident? was this the initial firing of the device or was the device reloaded? if reloaded, who reloaded the device and what is their experience? if reloaded, was there difficulty in reloading? if reloaded, what was done to ensure that the cartridge was snapped in prior to closing the device? how was the retaining pin placed (manually or automatic)? when was the staple retaining cap removed? what provisions did the surgeon take to ensure the tissue was lying evenly within the jaws? was the device difficult to close? was the device closed and repositioned multiple times prior to firing? was the device difficult to fire? was the distal transection completed in one or multiple firings?.Can more information be provided about staple form? what is the current status of the patient? response: i¿m sorry, i don¿t have any additional information.The surgeon has not received an in service since this incident.He has not been available.Device analysis: the product was returned to ethicon endo surgery for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample revealed that the cs40b device was received with no apparent damage and with no reload present.The device was tested for functionality with a test reload and the device fired, forming all staples and cutting as intended.The cut line and the staple line were completed and the staples meet the staple form release criteria.The device lockout and the reload lockout were functional.As part of ethicon endo surgery¿s quality process all devices are manufactured, inspected, and released to approved specifications.Although no conclusion could be reached on the cause of the reported event, the instructions for use do contain the following caution: either manually advance the retaining pin using the actuator button on top of the handle to capture the tissue within the jaw opening, or automatically advance the retaining pin by squeezing the closure trigger.Note that there is an audible click halfway through the closure stroke indicating that the device is in the intermediate position.In the intermediate position, the pin is fully seated in the anvil capturing the tissue, and the jaws are partially open.Reposition tissue within the instrument if desired.The closure trigger can be released at this point, and the instrument will maintain its jaw opening to allow for final positioning of the tissue to be cut and stapled.The retaining pin is fully engaged.Squeeze the closure trigger and handle together until the closure trigger is latched.Listen for an audible click.When the closure trigger is latched, the firing trigger moves to the ready-to-fire position.The cartridge has clamped onto the tissue which is ready to be cut and stapled.Ensure that the closing stroke is completed.All fingers should be completely removed from the closing trigger to ensure that the closing system holds.The event described could not be confirmed as the device performed without any difficulties noted and no cartridge was returned for analysis.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformance's were identified.

• Brand Name: CONTOUR CURVED CUTTER STAPLER
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo ; * ; 6107428552
• MDR Report Key: 13904656
• Report Number: 3005075853-2022-01819
• Device Sequence Number: 4590215
• Product Code: GDW
• UDI-Device Identifier: 10705036012399
• UDI-Public: 10705036012399
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K040038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/25/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2026
• Device Model Number: CS40B
• Device Catalogue Number: CS40B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/03/2022
• Initial Report FDA Received Date: 03/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown