MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. POWERED 60 ECHELON +, 440MM SHAFT; STAPLE, IMPLANTABLE

Model Number PLEE60A

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/06/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch #unk.Attempts have been made to retrieve the device.To date, the device has not been returned.If the device or further details are received at a later date, a supplemental medwatch will be sent.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.

Event Description

It was reported that during a lap gastric sleeve, the auto-reverse button did not work and the device had to be opened manually.Surgery was not delayed due to the event and was successfully completed.No fragments were generated and there were no patient consequences.No other medical intervention was required.

Manufacturer Narrative

(b)(4).Date sent: 03/30/2020 d4: batch # t5e42a device analysis: the analysis found that one plee60a device was returned with no apparent damage and with one gst60b 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 meet the staple release criteria.The event described could not be confirmed as the device performed without any difficulties noted.The device opened and closed without any difficulties noted.Once the device completed the firing sequence the knife returned home as intended.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.Performed by (b)(6).

• Brand Name: POWERED 60 ECHELON +, 440MM SHAFT
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 9775670
• MDR Text Key: 199085842
• Report Number: 3005075853-2020-01359
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036014614
• UDI-Public: 10705036014614
• 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: 02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2020
• 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: PLEE60A
• Device Catalogue Number: PLEE60A
• Device Lot Number: T94M8G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2020
• Date Manufacturer Received: 03/05/2020
• Patient Sequence Number: 1