MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PWRD ECH FLEX 60MM 44CM SHAFT; STAPLE, IMPLANTABLE

Model Number	PLE60A
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	03/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Batch # unk.As the device was not returned, an analysis investigation could not be performed.A conclusion could not be reached as to what may have caused or contributed to the event.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.Additional information was requested, and the following was obtained: response from sales rep.: when in firing sequence did device stop? how far did it cut and staple? not much.How was the device eventually removed form tissue? yes.Why did the surgeon need to convert to open? yes.Was the convert to open due to the difficulties experienced with device? yes.Does the surgeon believe that the reoperation was associated to the difficulties experienced with device? maybe.What was found during the reoperation and how was it addressed? they find a lot of bleeding in the major vessels.But the stapler line is ok.What is the current patient status? i don't know now but until (b)(6) he still in the uci waiting for his translation to another room with less cares.
Event or Problem Description
It was reported that the echelon stops working, apparently the battery has run out.They must open and reverse the blade manually.The echelon cut but not staple.They changed the echelon to continue the surgery, but they had to convert to open surgery due to bleeding.They had to reoperate for bleeding somewhere else (near the spleen) on sunday at 1:00 pm.

• 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 ; * 00969
• MDR Report Key: 9948161
• Report Number: 3005075853-2020-02096
• Device Sequence Number: 11621958
• Product Code: GDW
• UDI-Device Identifier: 10705036014300
• UDI-Public: 10705036014300
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 03/16/2020

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: 08/31/2022
• Device Model Number: PLE60A
• Device Catalogue Number: PLE60A
• Device Lot Number: T94G1H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/16/2020
• Initial Report FDA Received Date: 04/10/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention