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	01/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) date sent: 2/28/2024 b3: exact event date unk, entered 1/1/2024 as only the year was provided.D4: batch # 299c71 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 revealed that the sc45a device was returned with was returned with nozzle damaged(burned) and with one gst45w reload loaded in the device.The reload was received fully fired.The device was tested for functionality in the articulated position with a test reload and achieved its complete firing sequence without any difficulties.The staple line and cut line were complete and the staples meet the staple release criteria.It is possible that the damage on the nozzle was due to improper use of the device.Please reference the instruction for use for more information.Although no conclusion could be reach on the cause of the reported event, the instructions for use do contain the following caution: the complete firing action requires 4 complete strokes to cut the full reload length and return the knife to its home position.For each stroke, squeeze and release the firing trigger completely with a continuous, smooth stroke until it rests on the closing trigger.The numbers on the stroke count indicator will advance with each stroke.After the third stroke, the knife direction indicator will display an arrow pointing towards the proximal end of the instrument to indicate the knife is in the return mode.At the end of the fourth stroke, the stroke count indicator will display ¿0¿ to indicate the knife has returned to its home position.The status of the transection can also be determined by observing the knife blade indicator throughout the firing action.The event described could not be confirmed as the device performed without any difficulties noted.Device history review a manufacturing record evaluation was performed for the finished device batch number 299c71, and no non-conformances were identified.
Event or Problem Description
It was reported that during an unk procedure, after the surgeon completed a few staple.The equipment firing trigger was stuck, so the surgeon can't fire the reload.The surgeon directly changed to another equipment.There was no delay in the surgery and completed successfully.No patient consequences reported.

• Brand Name: ECHELON FLEX 45 COMPACT
• 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 ; PR ; 3035526892
• MDR Report Key: 18800571
• Report Number: 3005075853-2024-01730
• Device Sequence Number: 12598264
• Product Code: GDW
• UDI-Device Identifier: 10705036002697
• UDI-Public: 10705036002697
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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
• Report Date (Section B): 02/28/2024

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: 01/31/2026
• Device Catalogue Number: SC45A
• Device Lot Number: 299C71
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2024
• Initial Report FDA Received Date: 02/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2023
• 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