MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. FLEX 60 ARTICULATING; STAPLE, IMPLANTABLE

Catalog Number EC60A

Device Problems Defective Component (2292); Failure to Form Staple (2579)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/08/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).Batch # unk.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.The manufacturing record evaluation was performed, and the manufacturing criteria was met prior to the release of this batch/lot.Additional information requested and received: can you please provide more details? did the safety lockout engage (no staples or a cut line delivered beyond the lockout)? not according to the user.The staple lone was engaged bit incomplete.Or, did the stapler partially fire (the staple line and cut line approximately equal in length but did not finish the firing cycle)? yes.Did the device deliver any staples? yes, but the result was an incomplete line.If yes, were the staples that deployed into the tissue formed in the proper closed b-formation? not all of them.

Event Description

It was reported that the client had incomplete anastomosis with two consecutive echelon flex endopath 60mm staplers.They ended up using a third device from a different lot# to finish the job as all of the initial lot# was suspected to be defective.No patient consequence reported.

Manufacturer Narrative

(b)(4).Batch # t5a771.Investigation summary: the analysis found that one ec60a device was returned with no apparent damage and with no cartridge reload present.The device was tested for functionality in the articulated position with a test cartridge reload and achieved its complete firing sequence without any difficulties.The staple line was complete, and the staples meet the staple form release criteria.The event described could not be confirmed as the device performed without any difficulties noted.There may have been other circumstances or issues that occurred during the use of the device that we were unable to duplicate during our laboratory analysis.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

• Brand Name: FLEX 60 ARTICULATING
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8680527
• MDR Text Key: 148020269
• Report Number: 3005075853-2019-19549
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036001706
• UDI-Public: 10705036001706
• Combination Product (y/n): N
• PMA/PMN Number: K081146
• 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: 05/21/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 12/23/2021
• Device Catalogue Number: EC60A
• Device Lot Number: T92E29
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Initial Date Manufacturer Received: 05/21/2019
• Initial Date FDA Received: 06/07/2019
• Supplement Dates Manufacturer Received: 06/28/2019
• Supplement Dates FDA Received: 07/24/2019
• Patient Sequence Number: 1