MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. GOLD RELOAD FOR ECHELON 45; STAPLE, IMPLANTABLE

Catalog Number	ECR45D
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 11/30/2023.D4: batch # 101c78.Investigation summary: the product was returned to ethicon endo-surgery for evaluation.Visual inspection and functional testing were conducted on the returned reload.Visual analysis of the returned sample determined that one ecr45d reload was received for analysis; it was noted to be damaged and bent at the proximal end.The reload was received unfired.Upon evaluation of the reload, the reload pan was noted to be partially dislodged at the proximal end side, with 8 double drivers and 2 single drivers missing.No functional test was performed due to the condition of the reload.It is possible that the damage noted on the returned reload was due to improper handling of 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 101c78, and no non-conformances related to the reported complaint condition were identified.
Event or Problem Description
It was reported that during the unk surgery, noted that cartridge base loose and could not install.Changed the new one to complete surgery.There was no patient consequence reported.No additional information can be provided.

• Brand Name: GOLD RELOAD FOR ECHELON 45
• 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 ; PR ; 3035526892
• MDR Report Key: 18237489
• Report Number: 3005075853-2023-08867
• Device Sequence Number: 3225623
• Product Code: GDW
• UDI-Device Identifier: 10705036001737
• UDI-Public: 10705036001737
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 11/30/2023

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 Catalogue Number: ECR45D
• Device Lot Number: 225C33
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/02/2023
• Initial Report FDA Received Date: 11/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2022
• 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