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

Catalog Number	PCE45A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent 10/24/2024.D4 batch #unk.The device upon which this medwatch is based has been received, however, the evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.A manufacturing record evaluation was performed for the finished device pce45a lot number c9dx0n and no non-conformances were identified.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 a lung resection the spring of firing button fell off during the use of stapler.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 11/1/2024.D4 batch #892c02.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 pce45a device was returned with damaged shrouds and with no reload present.The device was tested for functionality in the straight position with a test reload and achieved its complete firing sequence.The staple line and cut line were complete and the staples meet the staple form release criteria.Upon further inspection, the firing trigger would not function as intended and felt loose.In order to verify the condition of the internal components, the device was disassembled, and the firing trigger spring was noted to be missing.In addition the firing trigger spring was not returned for its analysis.Based on the information currently available, a product issue was identified during the investigation of the sample received.The damage to the spring firing trigger is potentially related to a manufacturing process.This product issue will be addressed through ethicon endo surgery¿s quality system.No conclusion could be reached on what may have cause the shrouds to be damaged.A manufacturing record evaluation was performed for the finished device batch number 892c02, and no non-conformances related to the reported complaint condition were identified.

• 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
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 20523325
• Report Number: 3005075853-2024-08056
• Device Sequence Number: 9088084
• Product Code: GDW
• UDI-Device Identifier: 10705036014461
• UDI-Public: (01)10705036014461(17)270331(10)C9DX0N
• 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,Followup
• Report Date (Section B): 11/01/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: PCE45A
• Device Lot Number: C9DX0N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/09/2024
• Supplement Date Received by Manufacturer: 10/25/2024
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 11/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2024
• 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
• Patient Sex: Unknown