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	01/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent 2/26/2025.D4 batch #128d56.B3: exact date is unk.Assumed first month of the year.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 sr55 reload was received with no apparent damage.The reload had the swing tab in the locked position, the knife not completely in the doghouse and fully fired.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.No functional test was performed.The event described could not be confirmed as the reload was received fully fired.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.Although no conclusion could be reached on the cause of the reported event, the instructions for use do contain the following caution: do not forcibly the firing knob when it is in the pre-firing position and/or the alignment/latching lever is not engaged, as this action may prevent the instrument from firing properly.The firing knob can not be rotated from its pre-firing position unless the alignment/latching lever is engaged.As part of ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch number 128d56, and no non-conformances were identified.The lot#159d48 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.Additional information was requested, and the following was obtained: 1.Did the device staple? no, the device was not staple, stapler got locked out.2.If the device stapled, was the staple line complete? no, staple got locked out and staple line was not formed.3.If the device stapled, what was the shape of the staples (b-formation, irregular, legs straight)? there was no stapling done.4.Did the device cut? no 5.If the device cut, was the cut line complete? no 6.Were the cut line and staple lines equal? no, the cut line and staple lines are not equal because cartridge did not fire.7.Was the device fired across a staple line? no, cartridge did not fire.8.Did the reload lock out and would not work? yes 9.Did the reload begin to staple and cut, but then jammed? no stapling begin, there was no staple and cut.10.Did the device staple, but there was no cut line? no, the device was not staple, and there was no cut line.11.How was the procedure completed? by other reload.12.Could you please clarify if there were any patient consequences? no 13.Could you please clarify if there were any change in the post-operative care of the patient as a result of the event? no 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 filed as appropriate.
Event or Problem Description
It was reported that during a gastrectomy the device misfired.

• 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: 21468732
• Report Number: 3005075853-2025-01452
• Device Sequence Number: 3410459
• Product Code: GDW
• UDI-Device Identifier: 10705036002826
• UDI-Public: (01)10705036002826(17)290531(10)159D48(21)
• 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): 02/26/2025

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: 159D48
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/21/2025
• Initial Report FDA Received Date: 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2024
• 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