MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDO ILS 21MM, CURVED; STAPLE, IMPLANTABLE

Catalog Number	ECS21A
Medical Device Problem Code	Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an esophageal surgery, open the package and noted that some staples protruding.Changed to the new one to complete surgery.There was no patient consequence reported.No additional information can be provided.
Additional Manufacturer Narrative
(b)(4).Date sent: 9/14/2023 d4: batch #751a07 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 ecs21a device arrived with no apparent damage and with the safety disengaged.In addition, the retainer was not present.The breakaway washer was present and uncut, the staples were protruding inside the pockets and four were noted to be missing.Also, 2 protruding staples were observed with the legs bent.No functional test was performed to preserve evidence.The event reported was confirmed and it is related to improper use of the device.It should be noted that an inadvertent movement of the firing trigger after disengaging the safety might cause the staples to fall out.It is important to ensure that the adjusting knob is set in the firing range before disengaging the safety.Therefore, it is imperative that disengaging the safety is the last step prior to firing.Please reference the instruction for use for more information.Also, it should be noted that all devices are inspected 100% for staple presence by an automated vision system, and are visually inspected 100% as a final check.In addition, at finished goods the devices are visually inspected based on a sample.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 751a07, and no non-conformances were identified.

• Brand Name: ENDO ILS 21MM, 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: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 17749467
• Report Number: 3005075853-2023-06654
• Device Sequence Number: 12127864
• Product Code: GDW
• UDI-Device Identifier: 10705036003489
• UDI-Public: 10705036003489
• 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
• Report Date (Section B): 09/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: ECS21A
• Device Lot Number: X94V7A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/24/2023
• Initial Report FDA Received Date: 09/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown