MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ECHELON FLEX 60 COMPACT; STAPLE, IMPLANTABLE

Catalog Number	SC60A
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 5/9/2024 d4: batch # 435c40 investigation summary the product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that one sc60a device was returned with no apparent damage and with one ecr60w partially fired 1/16 reload present.The returned device and reload were tested for functionality in the articulated position by resetting and reloading it into the device.The device achieved its complete stroke firing sequence without any difficulties.The staple line and cut line were complete and the remaining staples meet the staple form release criteria.In addition, the knife could return without any difficulties noted.It is possible that while loading the reload, the reload was pushed farther back than the reload alignment slot resulting in the knife pushing the one piece sled forward and locking the reload.Please reference the instruction for use for more information.As part of ethicon ¿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: 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.Squeeze firing trigger completely until it rests on the closing trigger.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 knife could return without any difficulties noted.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 435c40, and no non-conformances were identified.
Event or Problem Description
It was reported that during the surgery, after fired, the knife moved to the distal end, but could not return knife automatically.Repeated many times to return knife.There was no patient consequence reported.No additional information can be provided.

• Brand Name: ECHELON FLEX 60 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 ; *
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 19277536
• Report Number: 3005075853-2024-03512
• Device Sequence Number: 20413271
• Product Code: GDW
• UDI-Device Identifier: 10705036002710
• UDI-Public: 10705036002710
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K081146
• 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): 05/09/2024

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: 04/30/2026
• Device Catalogue Number: SC60A
• Device Lot Number: A9D38R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/22/2024
• Initial Report FDA Received Date: 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ECR60W
• Patient Sex: Unknown