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

Model Number EC45A

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

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

Event Date 10/05/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.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.Is the current patient status known? was there any patient consequence or change in the post-operative care of the patient as a result of the event? (extended hospital stay, readmission, re-operation, etc.) if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that during a laparoscopic sigmoidectomy while clamped low in the pelvis the device fired twice normally.On the third firing they never heard the 'click' and the device would not come off of tissue.They depressed the red button to fire again and it still would not come off of tissue.The surgeon created a hole above the staple line so he could insert a dolphin nosed instrument to pry the device off.The tissue appeared to be thicker than usual but not out of range.He used a different device to anastomose and one donut was formed but there was a hole in tissue.He then oversewed to complete the case.No patient consequences reported.No further information is available.

Manufacturer Narrative

(b)(4), date sent: 11/29/2021, d4: batch # 212a82.H6: component code =g04 investigation summary: the product was returned to ethicon endo surgery for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that one ec45a device was returned with the closing trigger and anvil in the closed position, and firing trigger in the opened position, articulated to the right, and the firing mechanism in the return stroke with the knife not fully back.In addition, the device was returned with an endopath xcel trocar 12 mm inserted in the shaft.Also.After further evaluation, the device could not be opened.No functional test was performed due to the condition of the device.The device was disassembled to verify the internal components and a clip was found lodged behind the knife, resulting in the firing mechanisms jamming.One gst45b reload was received fully fired and with damage on reload deck.As part of our quality process, the manufacturing records of this batch were reviewed, and the manufacturing standards were met prior to the release of this batch.The damage to the device and reload is consistent with the device being clamped over a hard object.To mitigate the potential for staples getting into the reload and interfering with the knife path during device firing, prior to reloading the device, rinse the anvil and reload jaw in sterile solution and then wipe the anvil and reload jaw to clean any formed but unused staples from the device.Additionally, proper care should be taken when placing the device on the tissue to be stapled, to ensure that no hard obstruction such as a clip is included with the tissue inside the jaws.Please reference the instruction for use for more information.As part of ethicon endo surgery¿s quality process all devices are manufactured, inspected, and released to approved specifications.

• 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: 12640492
• MDR Text Key: 281922407
• Report Number: 3005075853-2021-06222
• 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: 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: 10/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: EC45A
• Device Catalogue Number: EC45A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/11/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1