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

Catalog Number	CS40B
Medical Device Problem Codes	Failure to Fire (2610); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an open sigmoidectomy, the knife ran but the staple did not deploy.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.
Additional Manufacturer Narrative
(b)(4).Date sent 10/30/2023.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this lot.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
(b)(4).Date sent: 11/16/2023.Additional information received: the jaws could not be closed when the device was approached to the target tissue.The jaws could be closed at 2nd firing, but the staple was not deployed, and target tissue was cut when the firing lever was released.The tumor was benign tumor, and the cut line was above sigmoid, so oral side was sutured, and the echelon was used to cut anus side and completed the operation.The patient is stable.There was no unusual feeling when closing lever, firing lever was grasped at 2nd firing.The curved cutter could not be closed for 2nd times after it was fired, so there is no possibility that the device was fired for 2 times.The surgeon commented that the staple was not confirmed, so the sales rep believes that the staple was not in the device.
Additional Manufacturer Narrative
(b)(4).Date sent: 12/5/2023 d4: batch #129a60 investigation summary: the product was returned 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 a reload present.The reload was received void of staples, with the washer completely cut, drivers exposed and the knife recess below the cartridge deck.The reload was partially loaded in the device, these facts indicate that the reload was removed and reinserted incorrectly and/or incompletely after firing.The ledge of the lockout showed no indentations.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.As part of ethicon endo surgery¿s quality process all devices are manufactured, inspected, and released to approved specifications.Although no conclusion could be reach on the cause of the reported event, the instructions for use do contain the following caution: the firing stroke must be completed.Do not partially fire the instrument.Incomplete firing can result in malformed staples, incomplete cut line, bleeding, and leakage from the staple line and/or difficulty removing the device.The muscle stapling contour curved cutter stapler is designed with a feature that allows partial closing if a used cartridge reload, no cartridge reload, or an incorrectly inserted cartridge reload is in the instrument.In these cases, the device will close approximately one-third of the stroke and stop, but will return to the full open position when the closure trigger is released.The used or misloaded cartridge module should then be replaced with a new cartridge reload or, if no cartridge was present, a cartridge should be loaded in the instrument.After following the above steps, any device that does not close either partially or completely should not be used.The event described could not be confirmed as the device performed without any difficulties noted.A manufacturing record evaluation was performed for the finished device batch number 129a60, and no non-conformances related to the reported complaint condition 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
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 18029663
• Report Number: 3005075853-2023-07989
• Device Sequence Number: 5954585
• Product Code: GDW
• UDI-Device Identifier: 10705036012399
• UDI-Public: 10705036012399
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/05/2023

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: 12/31/2025
• Device Catalogue Number: CS40B
• Device Lot Number: V9444R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/22/2023
• Supplement Date Received by Manufacturer: 10/31/2023; 11/17/2023
• Initial Report FDA Received Date: 10/30/2023
• Supplement Report FDA Received Date: 11/16/2023; 12/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2021
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown