MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. 55 MM NTLC SELECTABLE RELOAD; STAPLE, IMPLANTABLE

Catalog Number	SR55
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 6/22/2024.D4: batch #623c02.Investigation summary: the product was returned for evaluation.Visual inspection was conducted on the returned reload.Visual analysis of the returned sample determined that the sr55 reload was received along with its opened packaging, with the right gripping surface damaged making the reload nonfunctional.It had the proximal 1 driver up and the remaining drivers down with staples present and a swing tab in the locked position.No functional testing was performed due to the condition of the reload.The event reported was confirmed and it is related to improper use of the reload.The condition on the returned reload is consistent with an improper loading technique.When loading the cartridge in the device, make sure the cartridge is inside the channel track and proper loading.It should be noted that the reload is designed to lockout, as a safety feature, if any staples have been fired from the cartridge reload.In addition, failure to complete the stroke may result in an incomplete staple line.Please reference the instruction for use for more information.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 623c02, and no non-conformances were identified.The lot#689c15 history records were reviewed and certified by external manufacturing that the manufacturing criteria were met prior to the release of the equipment.The certificate records are accessible through external manufacturing.
Event or Problem Description
It was reported that during a laparoscopic radical surgery for right colon cancer surgery, the device could not fire.Changed the new one to complete surgery.There was no patient consequence reported.No additional information can be provided.

• Brand Name: 55 MM NTLC SELECTABLE RELOAD
• 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: 19590928
• Report Number: 3005075853-2024-04607
• Device Sequence Number: 16972820
• Product Code: GDW
• UDI-Device Identifier: 10705036002826
• UDI-Public: 10705036002826
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K092577
• 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): 06/22/2024

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: SR55
• Device Lot Number: 689C15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/30/2024
• Initial Report FDA Received Date: 06/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown