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

Catalog Number	SC45
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch r59p2c.Additional information requested: did the device deliver any staples? if yes, were the staples formed properly? if yes, was the staple line complete? did the device cut? if yes, was the cut line complete? if yes, was there any issue with the cut line such as jagged, dull knife, irregular, etc? was there any difficulty opening the device? if yes, how was the device removed from the patient? if yes, did the jaws eventually open? additional information received: the customer stated that the device fired okay the first time, and reload was removed.The issue occurred trying to reload the device for the second time.They could not get the reload into the device.Investigation summary: the analysis results found that one sc45a was received instead of a sc45 device and with no visual non-conformances and one pan was found lodge inside the channel.The pan was removed from the channel and the device was tested for functionality in the articulated position with a test reload.The device fired, cut and formed all the staples as intended.The staple line was complete and the staples were note to have the proper b-formed shape.While no conclusion could be reached as to how the pan became dislodged from the reload, in addition it should be noted that a 100% inspections takes place during manufacturing to ensure the device meets the require specifications; in addition, a sample of the batch is inspected at fgqa.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 surgical procedure: "defect after first firing." there were no patient consequences reported.It is unknown how the case was completed.

• Brand Name: ECHELON 45 ENDOPATH STAPLER
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8568497
• Report Number: 3005075853-2019-18347
• Device Sequence Number: 19351732
• Product Code: GDW
• UDI-Device Identifier: 10705036002680
• UDI-Public: 10705036002680
• Combination Product (Y/N): N
• PMA/510(K) Number: K051002
• 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): 03/07/2019

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: 07/17/2021
• Device Catalogue Number: SC45
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/02/2019
• Initial Report FDA Received Date: 05/01/2019
• Patient Sequence Number: 1