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

Catalog Number PCEE60A

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/10/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # r5920z.Investigation summary: the analysis found that one pcee60a device was returned with no apparent damage and with a gst60d cartridge loaded on the device.The cartridge was received unfired.Upon evaluation, the device would not fire.In order to verify the condition of the internal components, the device was disassembled to verify the condition of internal components and the pcb board was noted to be non-functional.No conclusion could be reached as to what may have caused the pcb board to be damaged however, it should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure that the device meets the required specifications prior to shipment.No further functional testing could be performed due to the condition of the device.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.

Event Description

It was reported that during an unknown procedure, the knife did not move forward at the 3rd firing.Another device was used to complete the case.There were no adverse consequences to the patient.

• Brand Name: POWERED 60 ECHELON +, 280MM SHAFT
• Type of Device: 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: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 8188895
• MDR Text Key: 131379568
• Report Number: 3005075853-2018-15363
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/05/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 05/22/2021
• Device Catalogue Number: PCEE60A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2018
• Initial Date Manufacturer Received: 12/05/2018
• Initial Date FDA Received: 12/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1