MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PWRD ECH FLEX 60MM 44CM SHAFT; STAPLE, IMPLANTABLE

Catalog Number	PLE60A
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.The device history records were reviewed and the manufacturing criteria were met prior to the release of this batch/lot.
Event or Problem Description
It was reported that during the bariatric surgery,after fired, the knife moved to the distal end, but could not return knife automatically.Knife reverse button could not work.The surgeon removed the battery and rotated for 180 degree and reinserted the battery, but knife reverse button still could not work.Used manual override lever to return knife.There were no adverse consequences to the patient.No additional information can be provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).Batch # r57887.Device evaluation summary: the analysis found that one ple60a device was returned with no apparent damage and with no cartridge reload loaded on the device.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 but it was noted that the knife did not return to its home position.The device was disassembled to verify the condition of the internal components and a small flash was identified at the base of the firing post switch.This flash may cause the firing yellow actuator to be stuck, disabling the automatic return system of the knife.The device opened and closed without any difficulties noted.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances related to the reported complaint condition were identified.

• Brand Name: PWRD ECH FLEX 60MM 44CM SHAFT
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8285216
• Report Number: 3005075853-2019-16219
• Device Sequence Number: 11276878
• Product Code: GDW
• UDI-Device Identifier: 10705036014300
• UDI-Public: 10705036014300
• Combination Product (Y/N): N
• PMA/510(K) Number: K110385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: PLE60A
• Device Lot Number: R92A18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2019
• Initial Date Received by Manufacturer: 01/08/2019
• Supplement Date Received by Manufacturer: 01/25/2019
• Initial Report FDA Received Date: 01/29/2019
• Supplement Report FDA Received Date: 02/22/2019
• Patient Sequence Number: 1