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

Model Number	PCE45A
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #u5d972.(b)(4).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 an ecr45b reload present.The reload was received partially fired 1/10.The manual override door 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, the returned device and reload were tested for functionality in the straight position by resetting and reloading it into the device.The device achieved its complete firing sequence without any difficulties.The staple line and cut line were complete and the remaining staples meet the staple form release criteria.As part of our quality process, the manufacturing records of this batch was reviewed, and the manufacturing standards were met prior to the release of this batch.The event reported was confirmed and it is related to improper use of the device.It is possible that while loading the reload, the reload was pushed farther back than the reload alignment stop windows resulting in the knife pushing the one piece sled forward and locking the reload.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.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.
Event or Problem Description
It was reported that during the lobectomy surgery, after third fired, noted some staples malformed with irregular shape.Changed to a new one to complete surgery.There was no patient consequence reported.No additional information can be provided.

• 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 ; * 00969
• MDR Report Key: 12277027
• Report Number: 3005075853-2021-04441
• Device Sequence Number: 3970873
• Product Code: GDW
• UDI-Device Identifier: 10705036014461
• UDI-Public: 10705036014461
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 07/09/2021

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: 06/22/2023
• Device Model Number: PCE45A
• Device Catalogue Number: PCE45A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/09/2021
• Initial Report FDA Received Date: 08/04/2021
• Patient Sequence Number: 1