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

Catalog Number CS40G

Device Problem Use of Device Problem (1670)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 01/01/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 2/29/2024.D4 batch # unk.B3: only event year known: 2024.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.Additional information was requested, and the following was obtained: was the firing trigger advanced? were any staples deployed? what was the condition of the tissue? did the patient receive any preoperative chemotherapy or radiation? was there any concern about the condition of the tissue? was the device difficult to close? 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.

Event Description

It was reported that during an unknown procedure the contour was closed (not fired) and instead of holding it cut through tissue.Left with a very small cuff of tissue proximal to the anal tumor to re-try.Pt ended up with a abdomino-perineal resection of the anal canal instead of leaving tissues intact for chemoradiation.

Manufacturer Narrative

(b)(4).Date sent: 3/7/2024.

Manufacturer Narrative

(b)(4).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 determined that the cs40g device was received with no apparent damage with a reload loaded in the device and along with two reloads (b and c) inside a plastic bag.The reload loaded was received void of staples, the washer cut and with the knife recess below the cartridge deck.The reload (b) was received fully loaded with staples, washer uncut, some scratches around the batch area and the retaining pin in up position, showing that the reload was not properly loaded on the device.The reload (c) was received unfired and one scratch was noted around the batch area.The fact of the retaining pin up in the reload (b) indicate that the reload was removed and reinserted incorrectly and/or incompletely after the retainer was removed.The retaining pin of reload (b) was manually returned to home position and loaded in the device without difficulties.The device opened and closed without any difficulties.The device was tested for functionality with the returned reloads (b and c) and the device fired, forming all staples and cutting as intended.The cut lines and the staple lines were completed and the staples meet the staple form release criteria.It should be noted that 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 the complete guide loading and reloading the instrument.The event reported was confirmed and it is related to improper use of the device.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 (b)(6), and no non-conformances were identified.

• Brand Name: CONTOUR CURVED CUTTER STAPLER
• Type of Device: 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 ; PR ; 3035526892
• MDR Report Key: 18810551
• MDR Text Key: 336587931
• Report Number: 3005075853-2024-01772
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K040038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/05/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: CS40G
• Device Lot Number: A9E50X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/22/2024
• Initial Date FDA Received: 02/29/2024
• Supplement Dates Manufacturer Received: 03/01/2024; 03/07/2024
• Supplement Dates FDA Received: 03/07/2024; 04/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention