MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ECHELON FLEX 45 COMPACT; STAPLE, IMPLANTABLE

Catalog Number	SC45A
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unk procedure, the closure of the jaws, the stapler blocked and the knife didn't finish its run.No patient consequences were reported.
Additional Manufacturer Narrative
(b)(4).Date sent: 7/22/2024.B3: exact event date unk, entered 1/1/2024 as only the year was provided.D4: batch # unk.D4: udi: as the serial number for the device involved in the event was not provided, the full udi is currently not available.The device/photo upon which this medwatch is based has been received, however, the evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.Additional information was requested and the following was obtained: did the device staple the tissue? no.If so, was the staple line complete? 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.
Additional Manufacturer Narrative
(b)(4).Date sent: 8/13/2024; d4: batch # 467c47.Investigation summary: the product was returned to ethicon endo-surgery for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that one sc45a device was returned with the anvil bent upwards and with no reload present.Furthermore, the anvil knife slot was noted to be damaged.No functional test was performed due to the condition.Upon visual inspection of the knife, nicks were noted.As part of our quality process, the manufacturing records of this batch were reviewed, and the manufacturing standards were met prior to the release of this batch.It is possible that the combination of tissue and/or buttressing material compressed between the device jaws may have been beyond the indicated thickness of tissue that cannot compress to the indicated range for the selected cartridge.This may have caused excessive force to be applied to the underside of the solid steel anvil leading to this damage.It should be noted that a 100% inspection takes place during manufacturing to ensure the device meets the required specifications prior to shipments, in addition, a sample of the batch is inspected finished good quality assurance.One possible cause for this type of damage to the knife is when the device is fired over an already existing staple line, hard object or thicker tissue than indicated.Repeatedly firing across existing staple lines can also reduce the ability to cut cleanly.To mitigate the potential for staples getting into the cartridge and interfering with the knife path during device firing, prior to reloading the device, rinse the anvil and cartridge jaw in sterile solution and then wipe the anvil and cartridge jaw to clean any formed but unused staples from the device.Additionally, proper care should be taken when placing the device on the tissue to be stapled, to ensure that no hard obstruction such as a clip is included with the tissue inside the jaws.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 467c47, and no non-conformances were identified.
Additional Manufacturer Narrative
(b)(4).Date sent: 10/3/2024.Additional information was requested and the following was obtained: 1.Did the device begin cutting the tissue when fired or did it not cut at all? 2.If the device did cut, was the cut line complete? this add.Info is not retrievable sine a lot of time has passed.

• Brand Name: ECHELON FLEX 45 COMPACT
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 19793410
• Report Number: 3005075853-2024-05288
• Device Sequence Number: 7208326
• Product Code: GDW
• UDI-Device Identifier: 10705036002697
• UDI-Public: 10705036002697
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K051002
• 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,Followup,Followup
• Report Date (Section B): 10/03/2024

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 Expiration Date: 05/31/2026
• Device Catalogue Number: SC45A
• Device Lot Number: X96C2P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/26/2024
• Supplement Date Received by Manufacturer: 07/23/2024; 09/17/2024
• Initial Report FDA Received Date: 07/22/2024
• Supplement Report FDA Received Date: 08/13/2024; 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2023
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown