MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PWRD ECH FLEX 60MM 44CM SHAFT; STAPLE, IMPLANTABLE

Catalog Number	PLE60A
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unk procedure, the gripping of the handle was very tight locking it in between the surgery.The surgery was not delayed and i new stapler was used to complete the procedure.No patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Date sent: 8/15/2023.D4: batch # u5ef2c.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 ple60a device was returned with the handle shrouds partially opened and with no reload present.During the functional test, the motor sound was heard, and the knife didn't move forward to the lockout position, this is consistent with a device been bailout.In addtion, the articulation mechanism was noted to be damaged as would not hold the articulation setting.The device was disassembled to verify the condition of the internal components, the handle shrouds were removed and were found to be damaged, and the lever was damaged near interaction with the cam bailout.Also, the articulation bar was noted to be damaged.It should be noted after the manual override system is used the instrument is disabled and cannot be used for any subsequent firings.The bailout system was reset and then, it was tested for functionality in the straight 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.However, the cut was noted to be jagged due to a damaged knife.It is possible that an outside the normal use force was applied on the distal jaw creating a torque on the articulation components and breaking the articulation bar.One possible cause for this type of damage to the knife is when the device is fired over an already existing staple line, hard object, or thicker tissue than indicated.Repeatedly firing across existing staple lines can also reduce the ability to cut cleanly.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.It is possible that the damage on the bailout was due to improper handling of the device.After the manual override system is used, the instrument is disabled and cannot be used for any subsequent firings.To use the manual override, remove the access panel labeled ¿manual override¿ on the top of the instrument handle.The manual override lever will be exposed.Move the lever forward and backward until it can no longer be moved.The knife will now be in the home position.This can be verified by viewing the position of the knife blade indicator on the underside of the cartridge jaw.Discard the instrument.Please reference the instruction for use for more information.Device history review a manufacturing record evaluation was performed for the finished device batch number u5ef2c, and no non-conformances were identified.

• Brand Name: PWRD ECH FLEX 60MM 44CM SHAFT
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 17549972
• Report Number: 3005075853-2023-05783
• Device Sequence Number: 15127082
• Product Code: GDW
• UDI-Device Identifier: 10705036014300
• UDI-Public: 10705036014300
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K110385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/15/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: PLE60A
• Device Lot Number: U5EF2C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/26/2023
• Initial Report FDA Received Date: 08/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown