MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. POWERED 60 ECHELON +, 280MM SHAFT; STAPLE, IMPLANTABLE

Model Number PCEE60A

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/24/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch #u5aj2j.Investigation summary: the analysis found that one pcee60a device was returned with no apparent damage and with a gst60t reload present.The reload was received fully fired, with the pan detached from the reload.The device was tested for functionality in the straight position with a test reload and achieved its complete firing sequence without any difficulties.The staple line and cut line were complete and the staples met the staple release criteria.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformance were identified.It is also possible that handling by the customer could dislodge the pan.Dislodging as a result of reload removal from the device is the most likely scenario.Please reference the instruction for use for more information.It should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.Complaint information will be included in complaint trending that is reviewed on a regular basis to determine if further action is necessary.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that during a thoracoscopic pneumonectomy, the knife did not move forward during use.The sled of the cartridge moved forward slightly.The cartridge color was gold.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.

• Brand Name: POWERED 60 ECHELON +, 280MM SHAFT
• Type of Device: 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: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; * 00969 ; 6107428552
• MDR Report Key: 10510855
• MDR Text Key: 207229913
• Report Number: 3005075853-2020-04545
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036015017
• UDI-Public: 10705036015017
• Combination Product (y/n): N
• PMA/PMN Number: K110385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/30/2023
• Device Model Number: PCEE60A
• Device Catalogue Number: PCEE60A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2020
• Date Manufacturer Received: 08/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1