MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PWRD ECH FLEX 60MM 34CM SHAFT; STAPLE, IMPLANTABLE

Catalog Number PSE60A

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/26/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # r5a701.Investigation summary: the analysis found that one pse60a device was returned with no apparent damage and with the manual override door out of position; the override lever was up which denotes that the knife was manually returned to home position.It should be noted after the manual override system is used the instrument is disabled and cannot be used for any subsequent firings.An ecr60d cartridge reload was received partially fired 1/2.Upon evaluation of the reload, one piece sled and some drivers were noted to be damaged.No obvious damage to the cartridge deck was noted, which suggests the cartridge, may not have been fired over a hard object.As additional testing, the device was tested for functionality in the straight position with a test cartridge reload and achieved its complete 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.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.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.Can you please provide more event details? did the device partially fire (start to deploy staples and cut but could not be completed)? or, did the device staple properly, but not cut some or all of the tissue? if staples deployed into the tissue, were they formed in the proper closed b-formation? if no, please explain.Was the knife reverse switch attempted? if yes, did it function at all? please explain.

Event Description

It was reported that the surgeon fired stapler to liver tissue for transection, knife was moved forward about 3cm and stopped.Surgeon tried keep move it forward and back to start point but both works was not worked.Finally surgeon manually opened the jaw.No patient consequence reported.

Manufacturer Narrative

(b)(4).

• Brand Name: PWRD ECH FLEX 60MM 34CM SHAFT
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 9290767
• MDR Text Key: 176946145
• Report Number: 3005075853-2019-23313
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036014324
• UDI-Public: 10705036014324
• Combination Product (y/n): N
• PMA/PMN Number: K110385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/25/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/27/2022
• Device Catalogue Number: PSE60A
• Device Lot Number: T92W46
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2019
• Initial Date Manufacturer Received: 10/11/2019
• Initial Date FDA Received: 11/07/2019
• Supplement Dates Manufacturer Received: 10/11/2019
• Supplement Dates FDA Received: 11/07/2019
• Patient Sequence Number: 1
• Treatment: GOLD RELOAD FOR ECHELON 60.