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

Catalog Number PCEE60A

Device Problems Difficult to Insert (1316); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/13/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # p58v2a.Device analysis: the analysis results that one pcee60a device was returned with no visual non-conformances and without a cartridge reload present.In addition a cartridge pan was found lodged inside the channel.The pan was removed from the channel and the device was tested for functionality with a test reload.The device fired, cut and formed all the staples as intended.The staple line was complete and the staples were noted to have the proper b-formed shape.It is also possible that handling by the customer could dislodge the pan.Dislodgement as a result of the removal of the cartridge from the device is the most likely scenario.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.The batch history record was reviewed and no protocols or ncrs related to the complaint were found during the manufacturing process.

Event Description

Since the third fire it was not possible to insert the cartridge.The surgeon suggests that the blade slid back.The intervention was concluded using another device.There were no patient consequences.Procedure: thoracotomy.

• 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: 7763928
• MDR Text Key: 116869328
• Report Number: 3005075853-2018-11957
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 20705036015014
• UDI-Public: 20705036015014
• 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,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/23/2018

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: 10/27/2020
• Device Catalogue Number: PCEE60A
• Device Lot Number: P94F31
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2018
• Initial Date Manufacturer Received: 07/14/2018
• Initial Date FDA Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/27/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1