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

Catalog Number	EC45
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.The lot/batch was not provided; therefore, the manufacturing records could not be reviewed.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Additional information was requested and the following was obtained: can you please confirm the product code for the complaint device? is it ec45? yes.Or, is it ec45a? attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Did any piece of the reload fall into the patient? if yes, how was it retrieved? did this alter the procedure in any way?.
Event or Problem Description
It was reported that during an unknown procedure, the knife cuts into the magazine plastic parts from the magazine found in the instrument mouth.No harm to the patient.
Additional Manufacturer Narrative
(b)(4).Batch # p55t5v.The analysis found that one ec45 device was returned with no apparent damage and with an ecr45m partially fired 1/10 cartridge loaded on the device.The device was tested for functionality with the returned cartridge reload by resetting and reloading it into the device.The functional test demonstrated that the remaining staples in the cartridge reload formed properly and the instrument achieved its complete 3-stroke firing sequence without any difficulties.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.No damaged on the cartridge was noted.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.
Additional Manufacturer Narrative
Product complaint # (b)(4).Batch number: p55t5v.Investigation summary: the analysis found that one ec45 device was returned with no apparent damage and with an ecr45m partially fired 1/10 cartridge loaded on the device.The device was tested for functionality with the returned cartridge reload by resetting and reloading it into the device.The functional test demonstrated that the remaining staples in the cartridge reload formed properly and the instrument achieved its complete 3-stroke firing sequence without any difficulties.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.No damaged on the cartridge was noted.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.Additional information requested and received: did any piece of the reload fall into the patient? no.If yes, how was it retrieved? did this alter the procedure in any way? no.

• 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: 7707756
• Report Number: 3005075853-2018-11463
• Device Sequence Number: 1120666
• Product Code: GDW
• UDI-Device Identifier: 20705036001666
• UDI-Public: 20705036001666
• 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,Followup,Followup
• Report Date (Section B): 06/28/2018

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: 03/21/2020
• Device Catalogue Number: EC45
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2018
• Initial Date Received by Manufacturer: 06/28/2018
• Supplement Date Received by Manufacturer: 08/23/2018; 08/31/2018
• Initial Report FDA Received Date: 07/20/2018
• Supplement Report FDA Received Date: 08/27/2018; 09/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1