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

Model Number	SC45A
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #: unk.A manufacturing record evaluation was performed for the finished device lot/batch number, x9623z, and no non-conformances were identified.Additional information was requested, and the following was obtained: 1.Did the device deliver any staples? yes.If yes, were the staples formed properly? yes.If yes, was the staple line complete? yes.2.Did the device cut? yes.If yes, was the cut line complete? yes.If yes, was there any issue with the cut line such as jagged, dull knife, irregular, etc? the first second staple's cut line is fine,only third staple have question 3.Was there any difficulty opening the device? 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 the staple not grasp the tissue in third staple.No patient consequences reported.No further information is available.
Additional Manufacturer Narrative
(b)(4).Date sent: 4/6/2023.D4: batch # 958a15.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 one sc45a device was returned with no apparent damage and with no reload present.The device was tested for functionality in the articulated position with a test reload and achieved its complete firing sequence without any difficulties noted.The staple line and cut line were complete and the staples meet the staple release criteria.In addition, a tyvek was received along with the device.As part of ethicon endo surgery¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Although no conclusion could be reached on the cause of the reported event, the instructions for use do contain the following caution: once the firing cycle has been initiated, it should be completed by completing all four strokes of the firing cycle to return the knife to the home position.If it is necessary to interrupt the firing sequence, push the red manual knife reverse switch downward to reverse the knife motion; 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.To complete, squeeze the firing trigger completely until it rests on the closing trigger, after which the stroke count indicator will display ¿0¿ to indicate the knife has returned to its home position.The event described could not be confirmed as the device performed without any difficulties noted and no cartridge was returned for analysis.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.A manufacturing record evaluation was performed for the finished device batch number 958a15, and no non-conformances were identified.

• 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: 16506213
• Report Number: 3005075853-2023-01361
• Device Sequence Number: 6240245
• 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,Followup
• Report Date (Section B): 03/08/2023

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: 08/31/2025
• Device Model Number: SC45A
• Device Catalogue Number: SC45A
• Device Lot Number: X9623Z
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2023
• Supplement Date Received by Manufacturer: 03/17/2023
• Initial Report FDA Received Date: 03/08/2023
• Supplement Report FDA Received Date: 04/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown