MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ECHELON 60 ENDOPATH STAPLER; STAPLE, IMPLANTABLE

Catalog Number	EC60
Health Effect - Clinical Codes	Hematoma (1884); Blood Loss (2597); No Code Available (3191)
Date of Event	05/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).Batch # unk.The manufacturing record evaluation was performed, and the manufacturing criteria was met prior to the release of this batch/lot.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.What color cartridge was used? was buttressing material used? does the surgeon routinely wait 15 seconds prior to firing? was the device difficult to close or fire? were there any difficulties with device intraoperatively? how was the pulmonary hematoma diagnosed? why does the surgeon believe the hematoma is related to device? was the post op care of patient altered in any way? was the hospitalization extended more than customary for this complication? what is the current patient status?.
Event or Problem Description
It was reported that during the wedge resection of lung surgery, there were no air leaks or bleeding, but pulmonary hematoma and bloody sputum occurred one day after surgery.The patient is still in the hospital for observation now.

• Brand Name: ECHELON 60 ENDOPATH STAPLER
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8748449
• Report Number: 3005075853-2019-20169
• Device Sequence Number: 1668322
• Product Code: GDW
• UDI-Device Identifier: 10705036001690
• UDI-Public: 10705036001690
• 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): 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: EC60
• Device Lot Number: R92A2C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/05/2019
• Initial Report FDA Received Date: 07/01/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR