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

Model Number EC45A

Device Problems Mechanical Problem (1384); Failure to Fire (2610); Difficult to Open or Close (2921)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch #: unk.Date of event unknown.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.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.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.Was the device locked on tissue with the jaws closed? was there any difficulty opening the device? if yes, how was the device removed? did the jaws eventually open?.

Event Description

It was reported that when firing the trigger, the gun was stuck.It would not reverse although pushing the reverse button.No patient consequences reported.No further information is available.

Manufacturer Narrative

Pc-(b)(4).Date sent: 11/23/2021 additional information was requested and the following was obtained: 1.Was the device locked on tissue with the jaws closed? >> no 2.Was there any difficulty opening the device? >>yes 3.If yes, how was the device removed? >> device did not entry the abdomen.Jaws cannot close.4.Did the jaws eventually open? >>yes.

• Brand Name: ECHELON FLEX 45 STANDARD
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo ; 6107428552
• MDR Report Key: 12655545
• MDR Text Key: 277368617
• Report Number: 3005075853-2021-06258
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036001676
• UDI-Public: 10705036001676
• Combination Product (y/n): N
• PMA/PMN Number: K051002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EC45A
• Device Catalogue Number: EC45A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1