MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PWRD ECH FLEX 45MM 44CM SHAFT; STAPLE, IMPLANTABLE

Catalog Number	PLE45A
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch number: p57m6m.Investigation summary: the analysis results that one ple45a device was returned with no visual non-conformances and without a cartridge reload present.In addition a cartridge pan was found lodged inside the channel.The pan was removed from the channel and the device was tested for functionality with a test reload.The device fired, cut and formed all the staples as intended.The staple line was complete and the staples were noted to have the proper b-formed shape.It is also possible that handling by the customer could dislodge the pan.Dislodgement as a result of the removal of the cartridge from the device is the most likely scenario.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.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.
Event or Problem Description
It was reported that the echelon power 45 stapler (ple45a) used for bariatric procedure, after the 4th firing, it no longer allowed to fit the another load.

• Brand Name: PWRD ECH FLEX 45MM 44CM SHAFT
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8141699
• Report Number: 3005075853-2018-14919
• Device Sequence Number: 215800
• Product Code: GDW
• UDI-Device Identifier: 10705036014379
• UDI-Public: 10705036014379
• 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,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/03/2018

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: 09/03/2020
• Device Catalogue Number: PLE45A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2018
• Initial Report FDA Received Date: 12/07/2018
• Patient Sequence Number: 1