MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PWRD ECH FLEX 45MM 44CM SHAFT; STAPLE, IMPLANTABLE

Catalog Number	PLE45A
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during gastric section the stapler stopped after finishing the third stapling with a green load, requiring manual opening with subsequent replacement by a new stapler.No patient consequences were reported.
Additional Manufacturer Narrative
(b)(4).Date sent: 4/9/2024.D4: batch # p57y1t.Investigation summary:   the product was returned to ethicon endo-surgery for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample determined that one ple45a device was returned with no apparent damage, with a tyvek, and with no reload present.The manual override door out of position and missing; 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 subsequence firings.The bailout system was reset and then an attempt to fire the device was made, however, the device would not fire.Upon evaluation, the pcb board was noted to be non-functional.The device opened and closed without any difficulties noted.No conclusion could be reached as to what may have caused the pcb board to be damaged.Device history review: a manufacturing record evaluation was performed for the finished device batch number p57y1t, and no non-conformances were identified.

• Brand Name: PWRD ECH FLEX 45MM 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 ; PR ; 3035526892
• MDR Report Key: 19075999
• Report Number: 3005075853-2024-02776
• Device Sequence Number: 6900439
• Product Code: GDW
• UDI-Device Identifier: 10705036014379
• UDI-Public: 10705036014379
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/09/2024

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 Expiration Date: 08/30/2020
• Device Catalogue Number: PLE45A
• Device Lot Number: R93P5N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2024
• Initial Report FDA Received Date: 04/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2017
• 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