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

Catalog Number EC45A

Device Problem Separation Failure (2547)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2018

Event Type  malfunction  

Manufacturer Narrative

(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 device history records were reviewed and the manufacturing criteria were 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.Can you please clarify what is meant by ¿the jaw of the echelon flex was not opened.¿? was the device locked on tissue with the jaws closed? if yes, how was the device removed? did the jaws eventually open? was any part of the target tissue cut prior to the device locking? did the device lock-out (no staples deployed and no cut line started)? or, did the device start to deploy staples and cut but could not be completed (partially fire)?.

Event Description

It was reported that the jaw of the echelon flex was not opened.Patient consequence?: no.

Manufacturer Narrative

Product complaint # (b)(4).Additional information requested and received: can you please clarify what is meant by ¿the jaw of the echelon flex was not opened.¿? before the surgeon tried to approach device to the target tissue, the jaw was not opened at all.So, the device was discarded was the device locked on tissue with the jaws closed? before the device was accessed on the tissue, the jaw was not opened.If yes, how was the device removed? did the jaws eventually open? no, it did not.Was any part of the target tissue cut prior to the device locking? no, the tissue was not cut did the device lock-out (no staples deployed and no cut line started)? the device locked-out, before it was used.Or, did the device start to deploy staples and cut but could not be completed (partially fire)?.

Manufacturer Narrative

Product complaint # (b)(4).Batch # p5807n.Investigation summary: the analysis found that one ec45a 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 and cut line were complete and the staples were noted to have the proper b-form shape.Event could not be confirmed as the device opened and closed 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.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.

• Brand Name: ECHELON FLEX 45 STANDARD
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7282778
• MDR Text Key: 100658472
• Report Number: 3005075853-2018-08084
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• PMA/PMN Number: K051002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/26/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 08/19/2020
• Device Catalogue Number: EC45A
• Device Lot Number: P92714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2018
• Initial Date Manufacturer Received: 01/26/2018
• Initial Date FDA Received: 02/20/2018
• Supplement Dates Manufacturer Received: 02/25/2018; 03/22/2018
• Supplement Dates FDA Received: 03/20/2018; 03/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1