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

Model Number PSEE60A

Device Problems Failure to Advance (2524); Failure to Form Staple (2579)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/23/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # u5av2m.Investigation summary the analysis found that one psee60a device was returned with no apparent damage and with an ecr60g reload loaded on the device.The reload was received partially fired 1/3.The returned device and reload were tested for functionality in the straight position by resetting and reloading it into the device.The device achieved its complete firing sequence without any difficulties.The staple line and cut line were complete and the remaining staples meet the staple form release criteria.As part of our quality process, the manufacturing records of this batch was reviewed, and the manufacturing standards were met prior to the release of this batch.The partially fired is consistent with an incomplete or interrupted cycle.Please reference the instruction for use for more information.It should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.

Event Description

It was reported that during a laparoscopic gastrectomy, the knife did not move forward at the firing on the duodenum.There were deployed staples before the knife moved.No staples were deployed on the target tissue, but a lumbricoid-shaped staple and an unformed staple were found.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.

Manufacturer Narrative

(b)(4).Date sent: 11/13/2020; d4: batch # u5av2m.Investigation summary: the analysis found that one psee60a device was returned with no apparent damage and with an ecr60g reload loaded on the device.The reload was received partially fired 1/3.The returned device and reload were tested for functionality in the straight position by resetting and reloading it into the device.The device achieved its complete firing sequence without any difficulties.The staple line and cut line were complete and the remaining staples meet the staple form release criteria.As part of our quality process, the manufacturing records of this batch was reviewed, and the manufacturing standards were met prior to the release of this batch.The partially fired is consistent with an incomplete or interrupted cycle.Please reference the instruction for use for more information.It should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.

• 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: 10723023
• MDR Text Key: 214611211
• Report Number: 3005075853-2020-05506
• 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: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: PSEE60A
• Device Catalogue Number: PSEE60A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2020
• Date Manufacturer Received: 10/15/2020
• Patient Sequence Number: 1
• Treatment: GREEN RELOAD FOR ECHELON 60