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	02/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).Batch # r59e4l.Investigation summary: the analysis found that one ple60a device was returned with no apparent damage and with an ecr60b cartridge reload present.The cartridge reload was received with the one-piece sled detached and unfired making it nonfunctional.The device 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 were noted to have the proper b-form shape.Although no conclusion could be reached on why the one-piece sled is detached, it should be noted that each cartridge reload is 100% inspected through an automated vision system to ensure that the one piece sled is present prior to shipment.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.Additional information requested and received: please confirm the correct procedure date.Surgery was feb 13 around 12 pm and i reported it feb 14.Is the current patient status known? 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.
Event or Problem Description
It was reported that we had an procedure in the afternoon where an echelon ple60a was used that had a piece (fragment) that we did not know and did not allow to put the cartridge.Therefore the cartridge was not used either.
Additional Manufacturer Narrative
(b)(4).Photographic analysis: one photo was provided; the picture shows the one piece sled of a reload over what appears to be a napkin.Based on the photo alone the event describe is confirmed, however no conclusion or root cause could be determined.Please refer to the device analysis for full analysis details and conclusion.

• 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: 8416414
• Report Number: 3005075853-2019-17201
• Device Sequence Number: 19415000
• Product Code: GDW
• UDI-Device Identifier: 10705036014300
• UDI-Public: 10705036014300
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 02/14/2019

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: 06/30/2021
• Device Catalogue Number: PLE60A
• Device Lot Number: R9415V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2019
• Initial Date Received by Manufacturer: 02/14/2019
• Supplement Date Received by Manufacturer: 03/14/2019
• Initial Report FDA Received Date: 03/13/2019
• Supplement Report FDA Received Date: 04/08/2019
• Patient Sequence Number: 1