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	10/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # t5a144.Additional information was requested, and the following was obtained: what is the current patient status? ok was there any patient consequence or change in the post-operative care of the patient as a result of the event (extended hospital stay, readmission, re-operation, etc.)? no device analysis: the analysis found that one ple60a device was returned with no apparent damage and with the manual override door 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.No cartridge loaded on the device.The bailout system was reset and then, the device was noted to be nonfunctional.In order to evaluate the condition of the internal components the device was disassembled.Upon disassembling, evidences of corrosion were noted on the motor and shaft.No functional testing could be performed due to the returned condition of the motor.One possible cause for this condition may be the exposure of cleaning solution.Please note 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.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.
Event or Problem Description
It was reported that during an unknown procedure, blade did not move.Surgery was not delayed.Doctor used a new gun.The procedure was completed successfully.

• 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: 9490182
• Report Number: 3005075853-2019-24540
• Device Sequence Number: 19391931
• 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
• Report Date (Section B): 10/10/2019

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: 12/08/2021
• Device Catalogue Number: PLE60A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/05/2019
• Initial Report FDA Received Date: 12/18/2019
• Patient Sequence Number: 1