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

Catalog Number EC60A

Device Problems Break (1069); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/20/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch: r5aa6r.Investigation summary the ec60a device was received for analysis with no apparent damaged and with an ecr60b cartridge reload loaded on the device.The cartridge reload was received partially fired 1/3 and with damage on cartridge deck.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.The partially fired is consistent with an incomplete or interrupted cycle.The firing trigger functioned as intended and without any difficulties noted.The damage to the cartridge is consistent with the device being clamped over a hard object.To mitigate the potential for staples getting into the cartridge and interfering with the knife path during device firing, prior to reloading the device, rinse the anvil and cartridge jaw in sterile solution and then wipe the anvil and cartridge 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.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

Event Description

It was reported that during the splenectomy surgery, the knife could not move forward and the firing trigger was damaged on the 2nd firing.Changed the new one to complete surgery.There was no patient consequence reported.No additional information can be provided.

• 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: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 8757741
• MDR Text Key: 150157882
• Report Number: 3005075853-2019-20227
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/10/2019

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: 09/30/2021
• Device Catalogue Number: EC60A
• Device Lot Number: R94W12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2019
• Initial Date Manufacturer Received: 06/10/2019
• Initial Date FDA Received: 07/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/08/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1