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

Catalog Number PSEE60A

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/11/2018

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).Batch # r59y87.Investigation summary: the analysis found that one psee60a device was returned with the closure trigger broken and in the opened position.No cartridge reload present.No functional test was performed due to the condition of the device.The device was disassembled to verify the internal components and no additional anomalies were noted.It is possible that the device was clamped over an excess of tissue or a hard object, resulting in the damage to the closure trigger handle.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.He 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 a cystectomy, the surgeon pressed firing trigger and blade did not advance.Case completed with another device of the same product code.There were no patient consequences reported.

• Brand Name: POWERED 60 ECHELON +, 340MM 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: 8302925
• MDR Text Key: 136616227
• Report Number: 3005075853-2019-16376
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036014607
• UDI-Public: 10705036014607
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/27/2019

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: 08/06/2021
• Device Catalogue Number: PSEE60A
• Device Lot Number: R94E46
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2019
• Initial Date Manufacturer Received: 01/27/2019
• Initial Date FDA Received: 02/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1