MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ILS 33MM, CURVED; STAPLE, IMPLANTABLE

Catalog Number CDH33A

Device Problem Failure to Cut (2587)

Patient Problem Insufficient Information (4580)

Event Date 01/09/2024

Event Type  Injury  

Event Description

It was reported that during a bowel resection the circular staple stapled the tissue, but did not cut.To continue the procedure, a new circular stapler was opened.If other, describe - endometriosis, the procedure was successfully completed.Patient status/ outcome / consequences - yes.Patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)? increase of surgical time, change of surgical technique.

Manufacturer Narrative

(b)(4), date sent 1/25/2024, d4 batch #unk.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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: where on the bowel was the stapler fired? any unusual noise heard? why was there a change in the surgical technique? what was the patient consequences due to the change in surgical technique? what were the indications for surgery? what surgical procedure was performed? did the patient receive any preoperative chemotherapy or radiation? were there any issues experienced with the device in the initial surgical procedure? what healthcare professional fired the device and what is his/her experience with the device? where in the green gap setting scale was the indicator located prior to firing (low-b, middle-b, or high-b)? did the healthcare professional wait 15 seconds after closing the device and then retighten prior to firing? was the device difficult to close? was the device difficult to fire? how may counter-clockwise revolutions of the adjusting knob were used to open the device? did the healthcare professional receive audible & tactile feedback when firing the device? were the donuts inspected? if so, please describe.Was a complete transection of the white breakaway washer visually confirmed? were there any issues noted with staple formation at any point throughout the care of the patient? if so, please describe the shape and location.What is the current status of the patient? does the surgeon believe the post-operative complications were related to an alleged deficiency of the device or were there other contributing factors to include patient tissue condition? 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.

Manufacturer Narrative

(b)(4).Date sent: 3/12/2024.D4: batch #923a47.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 cdh33a device arrived with no apparent damage.The breakaway washer uncut and indented and there were no staples present.The device was reloaded with staples and tested for functionality with a test washer; the device formed all the staples, as well as completely cut the test media and the breakaway washer without incident.The staple line was complete, and the staples meet the staple form release criteria.The event reported was confirmed and it is related to improper use of the device.The condition of the washer indicates that the device had not been fired through a full firing stroke or possibly that the orange indicator was not fully into the safe green firing range.Before firing the device the orange indicator should be fully within the green range of the gap setting scale and the safety should not be released prior to firing.Also, if the firing sequence is not fully completed (the firing handle reaches its stopping point, and the firing trigger is parallel to the instrument handle) staples could be partially deployed without cutting the washer.Please reference the instruction for use for more 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 923a47, and no non-conformances were identified.

• Brand Name: ILS 33MM, CURVED
• 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: 18584001
• MDR Text Key: 333773568
• Report Number: 3005075853-2024-00741
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036003472
• UDI-Public: 10705036003472
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K983536
• 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
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CDH33A
• Device Lot Number: 908A60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2022
• 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
• Patient Age: 30 YR
• Patient Sex: Female