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

Model Number	ECR60M
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #: unk.Date of event is 2020.Event day and event month were not reported.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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 nephrectomy procedure, upon opening the reload, the metal tray on the reload was noted to be dislodged from the plastic cartridge.A new reload was opened.The procedure was completed with no patient consequences.
Additional Manufacturer Narrative
(b)(4).Date sent: 02/25/2021.D4: batch # t5eh2p.H6: component code = mechanical (g04).Device analysis: the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned reload.Visual analysis of the returned sample determined that one ecr60m reload was returned unfired with the reload pan partially dislodged from left proximal side.No functional test was performed due the condition of the reload.It should be noted that product failure is multifactorial.No conclusion could be reached on what may have caused the reload pan to dislodge.A manufacturing record evaluation was performed for the finished device batch number, 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
• MDR Report Key: 11142503
• Report Number: 3005075853-2021-00162
• Device Sequence Number: 607962
• Product Code: GDW
• UDI-Device Identifier: 10705036013792
• UDI-Public: 10705036013792
• Combination Product (Y/N): N
• 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: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2020

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: 10/30/2024
• Device Model Number: ECR60M
• Device Catalogue Number: ECR60M
• Device Lot Number: T4146R
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/08/2021
• Initial Date Received by Manufacturer: 12/15/2020
• Supplement Date Received by Manufacturer: 01/27/2021
• Initial Report FDA Received Date: 01/08/2021
• Supplement Report FDA Received Date: 02/25/2021
• Patient Sequence Number: 1