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

Catalog Number	SC60A
Medical Device Problem Code	Unintended Ejection (1234)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 12/20/2023 d4: batch # unk a manufacturing record evaluation was performed for the finished sc60a, with lot/batch number a9d21n, and no non-conformances were identified.The investigation has been completed based on the information provided to date.If further information is received at a later date, the file will be updated.Complaint information is trended on a regular basis to determine if further investigation is warranted accordingly.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 during a colectomy, the device was used inside the body cavity.Then, the entire cartridge came off during use.There were no staples or other residues in the body.After anastomosis, the device locked out when the surgeon attempted to fire with the dislodged cartridge again.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.
Additional Manufacturer Narrative
(b)(4).Date sent: 1/29/2024; d4: batch # 435c95.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 sc60a device was returned with no apparent damage and with a gst60b partially fired 1/16 reload loaded on the device.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, a tyvek was received along with the device.The event reported was confirmed and it is related to improper use of the device.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 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 435c95, and no non-conformances were identified.
Additional Manufacturer Narrative
(b)(4).Date sent: 4/19/2024.D4: batch # 435c95.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 sc60a device was returned with no apparent damage, with a tyvek, and with a gst60b partially fired 1/16 reload loaded on the device.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.The returned reload was loaded into the device without difficulties and did not fall out during the visual and functional testing.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.Device history review: a manufacturing record evaluation was performed for the finished device batch number 435c95, and no non-conformances were identified.

• Brand Name: ECHELON FLEX 60 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: 18367260
• Report Number: 3005075853-2023-09697
• Device Sequence Number: 18106951
• Product Code: GDW
• UDI-Device Identifier: 10705036002710
• UDI-Public: 10705036002710
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup,Followup
• Report Date (Section B): 04/19/2024

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: A9D21N
• 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: 11/24/2023
• Supplement Date Received by Manufacturer: 01/05/2024; Not provided
• Initial Report FDA Received Date: 12/20/2023
• Supplement Report FDA Received Date: 01/29/2024; 04/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2023
• 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: GST60B
• Patient Sex: Unknown