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

Model Number	ECS33A
Medical Device Problem Codes	Failure to Form Staple (2579); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure to Anastomose (1028)
Date of Event	01/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Batch # u5dj2a.Additional information was requested and the following was received: what were the indications for surgery? obstructing rectal cancer what surgical procedure was performed? robotic lar did the patient receive any preoperative chemotherapy or radiation? no, but limited prostate radiation in the past what bowel prep did the patient receive prior to surgery? mag citrate, dulcolax and miralax with limited response due to obstruction were there any issues experienced with the device in the initial surgical procedure? no what healthcare professional fired the device and what is his/her experience with the device? lo, np.Highly experienced where in the green gap setting scale was the indicator located prior to firing (low-b, middle-b, or high-b)? between 1/3 and 1/2- pretty snug did the healthcare professional wait 15 seconds after closing the device and then retighten prior to firing? waited 15 seconds without retightening but took about 30 seconds to slowly tighten was the device difficult to close? no was the device difficult to fire? no how many counter-clockwise revolutions of the adjusting knob were used to open the device? 1 and 1/2 did the healthcare professional receive audible & tactile feedback when firing the device? yes was a complete transection of the white breakaway washer visually confirmed? no 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.Yes.After the failed leak test, they were inspected closely and found to be completely open (right angles/3-sided square) right and left lateral and anterior what is the current status of the patient? received colostomy, discharged device analysis: the product was returned to ethicon endo surgery for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample revealed that the ecs33a device arrived with the anvil missing.Only casing half washer present and there were no staples present.The device was reloaded with staples, a new washer was placed on the device and it was tested for functionality with a test anvil.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: 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.The event described could not be confirmed as no malformed staples were observed and the device performed without any difficulties noted.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.
Event or Problem Description
It was reported that during a sigmoid colectomy procedure that after completing the firing sequence the stapler seemed to fire as normal and there were two intact donuts.When they went to look in the abdomen there was ¿stool everywhere¿, the staples never grabbed the tissue to do the anastomosis.Surgeon ended up preformed a colostomy on the patient.

• Brand Name: ILS 33MM, CURVED
• Common Device Name: 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: kara ditty-bovard ; 475 calle c; guaynabo ; * ; 6107428552
• MDR Report Key: 13417377
• Report Number: 3005075853-2022-00610
• Device Sequence Number: 11979559
• Product Code: GDW
• UDI-Device Identifier: 10705036012412
• UDI-Public: 10705036012412
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K940967
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/01/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2025
• Device Model Number: ECS33A
• Device Catalogue Number: ECS33A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/11/2022
• Initial Report FDA Received Date: 02/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown