MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ECHELON FLEX 45 LONG; STAPLE, IMPLANTABLE

Catalog Number	EC45AL
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.
Event or Problem Description
It was reported that during a laparoscopic appendectomy, a few months ago that the device closed on tissue, stapled and cut, but would not unlock.The surgeon wiggled the device until it removed from tissue.At this point they were finished with the procedure.There were no patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Batch # n57a2r.The analysis found that one ec45al device was returned with no apparent damage and with an ecr45w partially fired 1/10 cartridge loaded on the device.The returned device and cartridge reload were tested for functionality in the articulated position by resetting and reloading it into the device.The device achieved its complete stroke 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.It is possible that while loading the reload, the cartridge was pushed farther back than the cartridge alignment stop windows resulting in the knife pushing the one piece sled forward and locking the cartridge.Event could not be confirmed as the device opened and closed without any difficulties noted.The batch history record was reviewed and no protocols or ncrs related to the complaint were found during the manufacturing process.

• Brand Name: ECHELON FLEX 45 LONG
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7490621
• Report Number: 3005075853-2018-09586
• Device Sequence Number: 13501777
• Product Code: GDW
• UDI-Device Identifier: 20705036001680
• UDI-Public: 20705036001680
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K051002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2018

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: 10/25/2019
• Device Catalogue Number: EC45AL
• Device Lot Number: P92U21
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/03/2018
• Initial Date Received by Manufacturer: 04/11/2018
• Supplement Date Received by Manufacturer: 05/09/2018
• Initial Report FDA Received Date: 05/07/2018
• Supplement Report FDA Received Date: 06/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1