MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ILS 25MM, CURVED; STAPLE, IMPLANTABLE

Catalog Number CDH25A

Device Problems Failure to Cut (2587); Failure to Eject (4010)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/29/2023

Event Type  malfunction  

Event Description

It was reported that during an anterior resection using cdh25a, registrar firing the gun, did not hear audible crunch, no feel the tactile cut through the breakaway washer.On inspection when trying to open and remove the stapler, they noted the stapler had not completely cut through.A linear cutter was used to cut the device just above the anvil, and the device was then removed through the rectum.They proceeded to use a cdh29p to complete the anastomosis successfully.Leak test was performed and appeared as per dr ok.On inspection of the manual cdh25a, a distal donut had formed only.Surgery was delayed 30 minutes.

Manufacturer Narrative

(b)(4).Date sent 12/6/2023.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: 1.Could you please clarify if there were any patient consequences? 2.Could you please clarify if was any change in the post-operative care of the patient as a result of the event? 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: 12/19/2023.Additional information was requested, and the following was obtained: 1.Could you please clarify if there were any patient consequences? 2.Could you please clarify if was any change in the post-operative care of the patient as a result of the event? not that i am aware of and was not reported when speaking to the surgeon following the case.3.How is the patient doing post-op? are they following the normal clinical path? unknown.4.Was any additional medical intervention required? as described in original notes powered stapler was used to create the anastomosis.5.Has the patient shown any signs of developing a surgical site infection (ssi) due to the extended delay? unknown.

Manufacturer Narrative

(b)(4).Date sent: 2/26/2024.D4: batch #u5c937.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 cdh25a device arrived with no apparent damage.The breakaway washer was present, cut and there were no staples present, indicating that the device achieved a full firing stroke.The device was reloaded with staples, a new washer was placed on the device and it was tested for functionality.It fired and 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.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: 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.Ensure that the firing trigger is fully squeezed to ensure proper staple formation and cutting of tissue.Open the instrument by turning the adjusting knob counter-clockwise.For easy removal, only open the instrument one-half to three-fourths revolutions.To assure the anvil is free from tissue, rotate the instrument 90° in both directions.To withdraw the open instrument, gently pull out while simultaneously rotating.If excessive force is required to close the device, this may indicate there is too much tissue or thickened tissue in the device.Attempting to fire the instrument in this condition may result in poor staple line integrity with possible leakage or disruption.In addition, instrument damage or failure may result.The event described could not be confirmed as the device performed without any difficulties.A manufacturing record evaluation was performed for the finished device batch number u5c937, and no non-conformances were identified.

Manufacturer Narrative

(b)(4).Date sent: 2/14/2024.

• Brand Name: ILS 25MM, 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: 18277390
• MDR Text Key: 329917289
• Report Number: 3005075853-2023-09134
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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,Followup,Followup
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CDH25A
• Device Lot Number: U40949
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2020
• 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
• Treatment: LINEAR CUTTER