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	03/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an anastomosis the stapler reload got misfired.
Additional Manufacturer Narrative
(b)(4).Date sent 4/28/2025.D4 batch #160d74.Investigation summary: the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned reload.Visual analysis of the returned sample determined that the sr55 reload was received with no apparent damage with a stapler retainer placed and along with its opened packaging.The reload had the proximal 50 drivers up, the remaining drivers down with staples present, swing tab in the locked position and the knife not completely within the doghouse.The reload swing tab was reset in order to fire the cartridge and the knife was returned within the doghouse.The returned reload was tested with a test device and fired without any difficulties.The staple line was complete, and the staples meet the staple form release criteria.In addition, a tyvek was received along with the device.The event reported was confirmed and it is related to improper use of the device.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.It is possible that the knife exposed noted on the reload is consistent with the firing knob was not returned completely prior to opening the device causing that the knife not returned completely to its home position.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 160d74, 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: 1.Did the device staple? 2.If the device stapled, was the staple line complete? 3.If the device stapled, what was the shape of the staples (b-formation, irregular, legs straight)? 4.Did the device cut? 5.If the device cut, was the cut line complete? 6.Were the cut line and staple lines equal? 7.Was the device fired across a staple line? 8.Please provide details as to how the reload did not work.9.Did the reload lock out and would not work? 10.Did the reload begin to staple and cut, but then jammed? 11.Did the device staple, but there was no cut line? 12.If the device cut and stapled, were there any staples missing from the staple line? 13.How was the procedure completed? 14.Is the current patient status known? 15.Was there any patient consequence or change in the post-operative care of the patient as a result of the event? (extended hospital stay, readmission, re-operation, etc.).

• 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: orla o'mahony ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 21917976
• Report Number: 3005075853-2025-03104
• Device Sequence Number: 21090276
• Product Code: GDW
• UDI-Device Identifier: 10705036002826
• UDI-Public: (01)10705036002826(17)290630(10)160D74
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/28/2025

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: 160D74
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2024
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown