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

Catalog Number EC60A

Device Problems Positioning Failure (1158); Component or Accessory Incompatibility (2897)

Patient Problem Insufficient Information (4580)

Event Date 08/05/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 9/11/2023 d4: 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.A manufacturing record evaluation was performed for the finished device lot/batch number, a9cc3j, and no non-conformances were identified.Additional information was requested and the following was obtained: approximately how many mm was the trocar incision extended? -about 2-3 cm.Was the post operative care of the patient altered in any way due to the reported use of the device? -no.Did the surgeon straighten the device prior to attempting to remove from trocar? -no.Was there any damage identified on the trocar or the endo cutter? -no.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.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 an unk procedure, after the device fired, the endocutter cannot be removed from the trocar.The surgeon tried many times to remove the device but all failed.Finally change to open operation and remove the endocutter and trocar together.No further details were provided.No patient consequences reported.

Manufacturer Narrative

(b)(4).Date sent: 10/13/2023.D4: batch # 273c16.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 revealed that the ec60a device was returned articulated to the left side with a cb12lt trocar 12 mm inserted in the shaft and the jaws and closure trigger were returned in the closed position.Also, the joint cover was damaged and the knife was noted as partially advanced, the red manual knife reverse button was activated and the knife returned to the home position as expected.One gst60w reload was loaded on the device.The reload was received fully fired.The device was tested for functionality in the articulated position with a test reload and achieved its complete firing sequence without any difficulties.The staple line and cut line were complete and the staples meet the staple release criteria.Although no conclusion could be reach on the cause of the reported event, the instructions for use do contain the following caution: the instrument can only achieve a maximum articulation angle of 45º.When using body structures or organs as a grounding surface, particular attention should be placed to the visual cues and tactile feedback received from the instrument.When the maximum angle is reached, the force will increase indicating the maximum angle has been reached.Avoid applying excessive pressure to the tissue as tissue damage or tissue trauma may occur.The event described could not be confirmed as the device performed without any difficulties noted.The damage on the joint cover, it is possible that the device was attended to be pulled out from a trocar in the articulated position, resulting in the edge of the trocar damaging the joint cover.Device history review a manufacturing record evaluation was performed for the finished device batch number 273c16, and no non-conformances related to the reported complaint condition were identified.

Manufacturer Narrative

(b)(4).Date sent:(b)(6) 2024.Upon review of the additional information provided, it was concluded that this event does not meet the fda defined criteria for a serious injury and is being considered not reportable.It was confirmed by the operating surgeon that the incision was only upgraded by 2-3cm the post operative care was not altered and no surgical intervention was required.This event no longer meets the criteria of a serious injury and is considered not reportable.

• Brand Name: FLEX 60 ARTICULATING
• 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: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 17719822
• MDR Text Key: 323075820
• Report Number: 3005075853-2023-06488
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036001706
• UDI-Public: 10705036001706
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K081146
• 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,Followup
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EC60A
• Device Lot Number: A9CC3J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/14/2023
• Initial Date FDA Received: 09/11/2023
• Supplement Dates Manufacturer Received: 09/18/2023; 02/06/2024
• Supplement Dates FDA Received: 10/13/2023; 02/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention