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

Model Number	ECS33A
Medical Device Problem Code	Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # 274a79.Investigation summary: the product was returned for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample revealed that the ecs33a device arrived with no apparent damage and along with the staple retainer broken.Further analysis on the device shows one staple was missing from the pockets and the breakaway washer was uncut.No functional test was performed to preserve evidence.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 be the last step prior to firing.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.Please reference the instruction for use for more information.It should be noted that as part of our quality process all devices are manufactured, inspected, and released to approved specifications.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 the rectum procedure, open the packing and noted that some staples fell off.Changed the new one to complete surgery.There was no patient consequence reported.No additional information can be provided.

• 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: orla o'mahony ; 475 calle c; guaynabo ; * ; 3293480130
• MDR Report Key: 15391332
• Report Number: 3005075853-2022-05908
• Device Sequence Number: 17439059
• 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,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/09/2022

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 Expiration Date: 03/31/2026
• Device Model Number: ECS33A
• Device Catalogue Number: ECS33A
• Device Lot Number: V94W3Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/14/2022
• Initial Report FDA Received Date: 09/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown