MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PWRD ECH FLEX 45MM 28CM SHAFT; STAPLE, IMPLANTABLE

Model Number	PCE45A
Medical Device Problem Codes	Failure to Form Staple (2579); Failure to Fire (2610); Difficult to Open or Close (2921); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.
Event or Problem Description
It was reported that during the left lung tumor resection surgery, after fired with two ecr45gs, noted some staples malformed with irregular shape.Changed ecr45d, could not fire when severing tissue on the 3rd firing and then the knife is at the distal end at this time, but could not return knife automatically.Used manual override lever to return knife.Changed the new one to complete surgery.There was no patient consequence reported.No additional information can be provided.
Additional Manufacturer Narrative
(b)(4).Date sent: 6/30/2021.D4: batch # u5d295.H6: component code= g07.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 pce45a device was returned with no apparent damage and with one ecr45d reload not loaded in the device.The reload was received fully fired.The manual override door was out of position; the override lever was up which denotes that the knife was manually returned to home position.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.As part of our quality process, the manufacturing records of this batch number were reviewed, and the manufacturing standards were met prior to the release of this batch.As part of ethicon endo surgery¿s quality process all devices are manufactured, inspected, and released to approved specifications.Although no conclusion could be reach on the cause of the reported event, the instructions for use do contain the following caution: for difficult to open, squeeze the closing trigger, then simultaneously press the anvil release button on either side of the instrument.While pressure is still on the anvil release button, slowly release the closing trigger, for malformed staple, tissue thickness should be carefully evaluated before firing any stapler.Holding the jaws in place for 15 seconds after closing and prior to firing may result in better compression and staple formation.Refer to echelon reload product codes chart for tissue compression requirement (closed staple height) for each staple size.For would not fire, ensure battery pack is fully inserted into the device.An audible click will be heard when the battery pack is fully inserted (the instrument must be used within 12 hours of inserting the battery pack, the battery pack contains a built-in battery drain).Insert the reload by sliding it against the bottom of the cartridge jaw until the cartridge alignment tab stops in the reload alignment slot.Snap the reload securely in place.Remove the staple retaining cap and discard.Close the jaws of the instrument by squeezing the closing trigger until it locks in place.An audible click indicates that the closing trigger and the jaws are locked.When the jaws of the instrument are closed, the red firing trigger lock and firing trigger are exposed.Pull back the red firing-trigger lock to enable the firing trigger to be pulled.Fire the instrument by pulling the firing trigger; the motor will activate audibly.Continue to depress the trigger until the motor stops.To complete the firing sequence, release the firing trigger to activate the motor and automatically return the knife to home position where the motor will stop.In this position, the instrument is locked out until the jaws are opened and re-closed.For would not reverse knife automatic, slide the knife reverse switch forward to return the knife to home position.The event described could not be confirmed as the device performed without any difficulties noted.The device opened and closed without any difficulties noted.Once the device completed the firing sequence the knife returned home as intended.The knife reverse button worked properly during testing.There may have been other circumstances or issues that occurred during the use of the device that we were unable to duplicate during our laboratory analysis.

• Brand Name: PWRD ECH FLEX 45MM 28CM SHAFT
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 11819382
• Report Number: 3005075853-2021-02672
• Device Sequence Number: 3792973
• Product Code: GDW
• UDI-Device Identifier: 10705036014461
• UDI-Public: 10705036014461
• Combination Product (Y/N): N
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2021

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: 06/30/2023
• Device Model Number: PCE45A
• Device Catalogue Number: PCE45A
• Device Lot Number: U94L3T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2021
• Initial Date Received by Manufacturer: 04/14/2021
• Supplement Date Received by Manufacturer: 05/31/2021
• Initial Report FDA Received Date: 05/13/2021
• Supplement Report FDA Received Date: 06/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ECR45D; ECR45G X2