MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. POWERED 60 ECHELON +, 340MM SHAFT; STAPLE, IMPLANTABLE

Catalog Number PSEE60A

Device Problems Use of Device Problem (1670); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/20/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.

Event Description

It was reported that during a low anterior resection, the doctor couldn't load a reload into the cartridge, noting the end effector was deformed.A second like stapler was used to complete the procedure.There were no patient consequences reported.

Manufacturer Narrative

Product complaint # (b)(4).Batch # r58y54.Device evaluation: the analysis results that one psee60a 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 possible that handling by the customer could have dislodged 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 defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.

• Brand Name: POWERED 60 ECHELON +, 340MM SHAFT
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7971137
• MDR Text Key: 123965665
• Report Number: 3005075853-2018-13654
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036014607
• UDI-Public: 10705036014607
• 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
• Type of Report: Initial,Followup
• Report Date: 09/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2021
• Device Catalogue Number: PSEE60A
• Device Lot Number: R93M5D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2018
• Date Manufacturer Received: 10/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1