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

Catalog Number CDH25A

Device Problems Failure to Cut (2587); Adverse Event Without Identified Device or Use Problem (2993); Ejection Problem (4009)

Patient Problem Failure to Anastomose (1028)

Event Date 03/04/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent 3/12/2024.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.Additional information was requested, and the following was obtained: 1.Is the current patient status known? yes, patient is recovering well.No ongoing concerns at this point.2.Was there any patient consequence or change in the post-operative care of the patient as a result of the event? (extended hospital stay, readmission, re-operation, etc.) no.3.How is the patient doing post-op? are they following the normal clinical path? patient.Is recovering as expected and following normal clinical path.4.Was there any additional medical or surgical intervention? no.5.Was there any change in the patient¿s post-operative care due to the reported event? no.6.Was there an associated surgical delay due to the reported event? has the patient shown any signs of developing an ssi? there was delay as the anastomosis had to be revised at the time.This added an additional 2 ½ hrs to surgery time as documented in pc.There are no signs of ssi.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: can you please confirm product code? can you please clarify the ¿additional flap of tissue with two trocar holes through¿ it means? was there any difficulty in attaching the anvil to the device? what were the indications for surgery? 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? was a leak test performed? if so, what type and what was the result? was the staple line visualized endoscopically during the initial surgical procedure? how many days postoperative did the leak occur? how was the leak identified? what was observed at the site of the leak upon reoperation? how was the leak addressed? were there any issues experienced with the device in the initial surgical procedure? 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 a laparoscopic sigmoid colectomy for diverticular disease.Ifu for stapler followed however on removal the stapler was unable to be removed with ease.Device was rotated 90 degrees and 90 degrees.More force than was expected to be able to remove the stapler.On removal the doughnuts were observed to be incomplete proximally and distally complete however with an additional flap of tissue with two trocar holes through it.The leak test was positive with air escaping from anastomosis.The anastomosis was excised and revised with side to end anastomosis using cdh29p.Leak test was negative with 2x complete well formed doughnuts.The patient received an end to end anastomosis of distal stump (sigmoid) and descending needed to be revised due to incomplete doughnut.This added 2.5 hours to surgery time.The patient did have a diverticular disease.

• Brand Name: ILS 25MM, CURVED
• Type of Device: 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: kate karberg ; 475 calle c; guaynabo ; PR ; 3035526892
• MDR Report Key: 18897113
• MDR Text Key: 337586585
• Report Number: 3005075853-2024-02164
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036003458
• UDI-Public: 10705036003458
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CDH25A
• Device Lot Number: 599A57
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2022
• 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: 44 YR
• Patient Sex: Male