MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PWRD ECH FLEX 60MM 28CM SHAFT; STAPLE, IMPLANTABLE

Catalog Number	PCE60A
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent 1/9/2025.D4 batch #744c13.Investigation summary: the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that one pce60a device was returned with no apparent damage 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 event described could not be confirmed as no functional test could be carried out due to the condition of the device.This report is not intended to deny that you experienced a problem with the device.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.Although no conclusion could be reach on the cause of the reported event, the instructions for use do contain the following caution: 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.When positioning the stapler on the application site, ensure that no obstructions such as clips, stents, guide wires, etc.Are within the instrument jaws.As part of ethicon endo surgery¿s quality process all devices are manufactured, inspected, and released to approved specifications.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 no conclusion could be reached as to what may have caused the pcb board to be damaged.A manufacturing record evaluation was performed for the finished device batch number 744c13, and no non-conformances were identified.A manufacturing record evaluation was performed for the finished #pce60a, with lot/batch #c9d66h , and no non-conformances were identified.Additional information was requested, and the following was obtained: was there any other issue noted with the staple line other than bleeding (malformed staples, staple line missing staples, etc.)? -no.How was the bleeding controlled? -suture sewing.How much blood was lost (ml)? -unknown.Did the patient require a transfusion? -no.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that during an unknown surgery, after fired, the staple line and cut line are both complete.Noted oozing.To stop oozing with compression hemostasis.There were no adverse consequences to the patient.No additional information could be provided.

• Brand Name: PWRD ECH FLEX 60MM 28CM 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: 21123435
• Report Number: 3005075853-2025-00298
• Device Sequence Number: 12647008
• Product Code: GDW
• UDI-Device Identifier: 10705036014478
• UDI-Public: (01)10705036014478(17)261231(10)C9D66H
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/10/2025

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 Catalogue Number: PCE60A
• Device Lot Number: C9D66H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/03/2025
• Initial Report FDA Received Date: 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/07/2024
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GST60B.
• Patient Sex: Unknown