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 10/28/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.The manufacturing record evaluation was performed, and the manufacturing criteria was met prior to the release of this batch/lot.

Event Description

It was reported that during a thoracoscope left upper lobectomy and lower right lobectomy, the knife stopped at the third firing on the separation of the lung parenchyma.The same event continued after clamping and waiting for 40 seconds after firing with another cartridge the knife moved a little but stopped with a metallic sound after waiting for 1 minute at the third firing.However, the nurse found that the anvil part of the device was damaged.The 8th firing was done by changing the device.The device was used on the lung.Another device was used to complete the case.There were no adverse consequences to the patient.

Manufacturer Narrative

Product complaint # (b)(4).Batch # t5dn4n.The analysis results found that one psee60a device was returned with the anvil bent upwards and with two gst60t reloads present.The reload (b) was received partially fired 1/16.The reload (c) was received fully fired.Furthermore the anvil knife slot was noted to be damaged.No functional test was performed due the condition.It is possible that the combination of tissue and/or buttressing material compressed between the device jaws may have been beyond indicated thickness or tissue that cannot compress to the indicated range for the selected cartridge.This may have caused excessive force to be applied to the underside of the solid steel anvil leading to this damage.It should be noted that a 100% inspection takes place during manufacturing to ensure the device meets the required specifications prior to shipments, in addition, a sample of the batch is inspected at fgqa.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

• 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: 9354826
• MDR Text Key: 199848238
• Report Number: 3005075853-2019-23646
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 10/28/2019

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: 08/27/2022
• Device Catalogue Number: PSEE60A
• Device Lot Number: T94D9D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2019
• Initial Date Manufacturer Received: 10/28/2019
• Initial Date FDA Received: 11/21/2019
• Supplement Dates Manufacturer Received: 11/26/2019
• Supplement Dates FDA Received: 12/13/2019
• Patient Sequence Number: 1
• Treatment: GST60T X 2.