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

Model Number	EC45AL
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # 497a87.Investigation summary: the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample revealed that the ec45al device was returned with no apparent damage and with one gst45w reload loaded in the device and it was returned slightly damaged on the border of the proximal end.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.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.The damage to the reload is consistent with the device being clamped over a hard object.To mitigate the potential for staples getting into the reload and interfering with the knife path during device firing, prior to reloading the device, rinse the anvil and reload jaw in sterile solution and then wipe the anvil and reload 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.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, and no non-conformances were identified.
Event or Problem Description
It was reported that during a laparoscopic colon procedure the device would not fire and locked out.A new device was used to complete the case with no patient consequences.

• Brand Name: ECHELON FLEX 45 LONG
• 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: 15828227
• Report Number: 3005075853-2022-08075
• Device Sequence Number: 12248032
• Product Code: GDW
• UDI-Device Identifier: 10705036001683
• UDI-Public: 10705036001683
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/18/2022

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: 09/30/2024
• Device Model Number: EC45AL
• Device Catalogue Number: EC45AL
• Device Lot Number: V96A3L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/04/2022
• Initial Report FDA Received Date: 11/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown