MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. GRAY RELOAD FOR 60MM ECHELON; STAPLE, IMPLANTABLE

Catalog Number	ECR60M
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 3/21/2024.D4: batch # 921a13.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.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 an peritonectomy procedure, a reload was opened and found to be bent/broken.No further details were provided.No patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Date sent: 5/1/2024.D4: batch # 876a98.Investigation summary: the product was returned to ethicon endo-surgery for evaluation.Visual inspection was conducted on the returned reload.Visual analysis of the returned sample determined that one ecr60m reload was received unfired, with the one-piece sled slightly out of position, with pan bend and partially dislodged from right side making it nonfunctional.No functional test was performed due to the condition of the reload.It is also possible that handling by the customer could dislodge the pan.Dislodgement as a result of the removal of the reload from the device is the most likely scenario.It is possible that when removing the staple retainer in an upward and distal to proximal sliding manner prior to loading the reload into the device can eject the sled from the proximal end of the reload.The ifu instruct the user to leave the staple retainer in position until the reload is loaded into the device.Please reference the instruction for use for more information.Device history review: a manufacturing record evaluation was performed for the finished device batch number 876a98, and no non-conformances were identified.

• Brand Name: GRAY RELOAD FOR 60MM ECHELON
• 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 ; PR ; 3035526892
• MDR Report Key: 18949530
• Report Number: 3005075853-2024-02302
• Device Sequence Number: 15430257
• Product Code: GDW
• UDI-Device Identifier: 10705036013792
• UDI-Public: 10705036013792
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 05/01/2024

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 Catalogue Number: ECR60M
• Device Lot Number: 921A13
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/05/2024
• Supplement Date Received by Manufacturer: 04/12/2024
• Initial Report FDA Received Date: 03/21/2024
• Supplement Report FDA Received Date: 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2022
• 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