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

Catalog Number PSEE60A

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/28/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.We did not receive a batch or lot number for the product involved in this complaint.Therefore, we were unable to check manufacturing records for any related non-conformance.Additional information received: there was oozing on the stapling line including the malformed staples, but it was stopped by astriction.The devise was used by the breast surgeon who was not used to it.Actually, the knife returned after firing.It was worked pulse fire continuously and the surgeon was not able to hear the returning sound and there was malformed staples at the tip of the tissue.As a result, the surgeon misunderstood the knife did not return and he was able to open the jaw.There was no mention about it.The patient is stable.

Event Description

It was reported that during a thoracoscope pneumonectomy, it was found that the deployed staples at the tip were unformed, and the knife did not move forward.Since the lung parenchyma could not be moved and the cartridge jaw was used downward, the position of the knife could not be confirmed at the tip.The knife reverse switch and the manual override lever was used but did not work.Then the open/close operation was confirmed again, the jaw opened smoothly.The target tissue was quite thick.There were no adverse consequences to the patient.

Manufacturer Narrative

(b)(4).Batch # t5at1x.Investigation summary: the analysis found that one psee60a device was returned with no apparent damage and with one gst60g cartridge loaded in the device.The cartridge reload was received fully fired.The manual override door was out of position; the override lever was up which denotes that the knife was manually returned to home position.It should be noted after the manual override system is used the instrument is disabled and cannot be used for any subsequent firings.The bailout system was reset and then, it 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 meets the staple release criteria.The event described could not be confirmed as the device performed without any difficulties noted.This report is not intended to deny that you experienced a problem with the device.There may have been other circumstances or issues that occurred during the use of the device that we were unable to duplicate during our laboratory analysis.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformance 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: 9356506
• MDR Text Key: 203876899
• Report Number: 3005075853-2019-23662
• 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: 02/09/2022
• Device Catalogue Number: PSEE60A
• 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: GST GREEN RELOAD, 60MM, 6 ROW