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

Model Number	ECS33A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure to Anastomose (1028)
Date of Event	03/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date sent: 5/12/2023.Batch # unk.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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.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? what was the purse string technique that was used to put the anvil in place? 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 many 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.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 was the leak identified? how was the leak addressed? what was observed at the site of the leak upon reoperation? what is the current status of the patient? 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 field as appropriate.
Event or Problem Description
It was reported that there was a post-op leakage.1-day after surgery a leakage was noted.The surgery procedure was normal.Procedure: unknown.
Additional Manufacturer Narrative
(b)(4).Date sent: 05/17/2023.H6: health effect ¿ clinical code = gastrointestinal system (e10).An analysis of the product could not be performed since a physical sample was not received for evaluation.The manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product is received at a later date, the investigation will be updated as applicable.Additional information was requested, and the following was received: what were the indications for surgery? rectal cancer what surgical procedure was performed? radical resection of rectal carcinoma did the patient receive any preoperative chemotherapy or radiation? unknown 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? good experience.What was the purse string technique that was used to put the anvil in place? unknown where in the green gap setting scale was the indicator located prior to firing (low-b, middle-b, or high-b)? unknown.Did the healthcare professional wait 15 seconds after closing the device and then retighten prior to firing? yes.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? 2 did the healthcare professional receive audible & tactile feedback when firing the device? yes were the donuts inspected? yes.The donut was complete.Was a complete transection of the white breakaway washer visually confirmed? yes.Were there any issues noted with staple formation at any point throughout the care of the patient? no.Was a leak test performed? if so, what type and what was the result? yes.Type was unknown.Was the staple line visualized endoscopically during the initial surgical procedure? unknown.How was the leak identified? unknown.How was the leak addressed? re-operation to enterostomy.What was observed at the site of the leak upon reoperation? unknown.What is the current status of the patient? discharged.

• Brand Name: ILS 33MM, CURVED
• Common Device Name: 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 ; 3035526892
• MDR Report Key: 16919020
• Report Number: 3005075853-2023-03242
• Device Sequence Number: 6910772
• Product Code: GDW
• UDI-Device Identifier: 10705036012412
• UDI-Public: 10705036012412
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2023

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: 08/31/2026
• Device Model Number: ECS33A
• Device Catalogue Number: ECS33A
• Device Lot Number: V95U89
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2023
• Supplement Date Received by Manufacturer: 05/15/2023
• Initial Report FDA Received Date: 05/12/2023
• Supplement Report FDA Received Date: 05/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2021
• 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