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

Model Number	CS40B
Medical Device Problem Codes	Failure to Form Staple (2579); Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # : 191a65.(b)(4).Additional information received: surgeon experience with device? 5 plus years.Are surgical procedure or device/videos available? no.Surgeon declined meeting with ethicon medical and engineering.In reference to the case on march 2nd, the staple line was compromised; the staples were not well formed, and the surgeon re-sewed.Steps for use was discussed and the following was shared by the sales rep.The device is used for the distal transection in creating the rectal stump.It cannot be confirmed if the distal transection was completed in one or multiple firings.It was shared that the surgeon should be familiar with reloading the device and the surgeon does the firing and fires plastic to plastic.At this time, it is unknown if the retaining pin is set automatically or manually or when the retaining cap is removed.It is unknown if there was difficulty in closing or firing the device.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 determined that the cs40b device was received with no apparent damaged and with a reload present.The reload was received void of staples, drivers exposed, and the knife recess below of the cartridge deck and washer missing.The device was tested for functionality with a test reload and it fired, cut, and formed the staples as intended.The cut line and the staple line were completed and the staples meet the staple form release criteria.It should be noted that to reload the device insert the new reload into the metal housing and snap it into position.The tracks on each side of the reload should be used as guides to align the reload within the jaws of the instrument.When the reload is properly aligned, push the reload into the instrument until it is fully seated.Remove the staple retainer.Check that the reload is held firmly within the jaws.If the reload is removed from the device, whether the reload is spent or not, and if the staple retainer has already been removed from the reload, the reload cannot be reloaded into the device.Please reference the instructions for use for additional information.As part of ethicon endo surgery¿s quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.If information is obtained that was not available for the initial report, a follow-up report will be field as appropriate.
Event or Problem Description
It was reported during a colorectal procedure, the 2nd firing of an echelon contour stapler misfired.It laid staples correctly but did not transect the tissue.Surgeon transacted tissue with no issue.No other information was provided.Patient was not harmed.

• 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: 13892371
• Report Number: 3005075853-2022-01793
• Device Sequence Number: 1779975
• Product Code: GDW
• UDI-Device Identifier: 10705036012399
• UDI-Public: 10705036012399
• Combination Product (Y/N): N
• 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): 03/24/2022

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 Expiration Date: 02/06/2026
• Device Model Number: CS40B
• Device Catalogue Number: CS40B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/02/2022
• Initial Report FDA Received Date: 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown