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

Model Number	ECR45D
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 6/16/2023 d4: batch # unk an evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.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 the surgery, after fired, noted the staples malformed.Changed another one to continue the surgery , could not fire.Changed the new one to complete surgery.There was no patient consequence reported.No additional information can be provided.
Additional Manufacturer Narrative
(b)(4).Date sent: 7/11/2023.D4: batch # 460a00.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 ecr45d reload was received for analysis.The reload was received partially fired 1/10.Upon evaluation of the reload, the reload pan was removed and it was noted that the one-piece sled was damaged.No obvious damage to the reload deck was noted, which suggests the reload, may not have been fired over a hard object.No functional test could be performed due to the condition of the reload.Based on the information currently available, a product issue was identified during the investigation of the sample received.The damage to the one-piece sled has been correlated to the design.This product issue will be addressed through ethicon endo surgery¿s quality system.A manufacturing record evaluation was performed for the finished device batch number 460a00, and no non-conformances were identified.
Additional Manufacturer Narrative
(b)(4).Date sent: 11/3/2023 investigation summary the device was sent to cincinnati for additional evaluation.Upon arrival in the cincinnati pi lab, it was found that there was reset witness marks present, a fracture failure generally from proximal direction was found, but it is possible that there was damage/cracking in the slot region before the final failure, it was found a crack through proximal body of sled, slight damage at proximal end of slot (likely from cartridge reset fixture) and it was confirmed that crack in sled body is indeed a crack and not a cut; no traces of foreign material on the inside surface of the proximal crack, also it was noted multiple damage one on the distal portion of bullnose on both sides and another on proximal end of sled body, which appears to be lower than the typical firing position; matching damage on the bullnose, the last damage noted was a sled body crack on a parting line; no differences noted in the complaint reload vs production reload, it was not indication of molding defect.

• Brand Name: GOLD RELOAD FOR ECHELON 45
• 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: 17143014
• Report Number: 3005075853-2023-04213
• Device Sequence Number: 20784175
• 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,Followup,Followup
• Report Date (Section B): 11/03/2023

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: 08/30/2026
• Device Model Number: ECR45D
• Device Catalogue Number: ECR45D
• Device Lot Number: 551A56
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/24/2023
• Supplement Date Received by Manufacturer: 06/16/2023; 10/12/2023
• Initial Report FDA Received Date: 06/16/2023
• Supplement Report FDA Received Date: 07/11/2023; 11/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown