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

Model Number PSEE60A

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/08/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # t5e557.Investigation summary: the analysis found that one psee60a device was returned with no apparent damage and with a gst60g cartridge reload loaded on the device.The cartridge was received partially fired 1/16 with eight double drivers out of position, making the reload non-functional.In addition, the cartridge pan was noted to be partially dislodged from left proximal side.The device was tested for functionality in the straight position with a test cartridge reload and achieved its complete firing sequence without any difficulties.The staple line and cut line were complete and the staples met the staple release criteria.A manufacturing record evaluation was performed for the finished device and the manufacturing criteria were met prior to the release of this lot/batch.No conclusion could be reached on what may have caused the cartridge pan to dislodge.In addition, 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.

Event Description

It was reported that during a colon resection, when activating the stapler, the blade did not advance and the battery was discharged.A new stapler was used to complete the procedure.There were no patient consequences.No additional information is available at this time.

• Brand Name: POWERED 60 ECHELON +, 340MM SHAFT
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; * 00969 ; 6107428552
• MDR Report Key: 9808664
• MDR Text Key: 200622212
• Report Number: 3005075853-2020-01518
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/09/2019

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: 09/30/2022
• Device Model Number: PSEE60A
• Device Catalogue Number: PSEE60A
• Device Lot Number: T94V45
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2020
• Initial Date Manufacturer Received: 02/12/2020
• Initial Date FDA Received: 03/09/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1