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

Catalog Number	PLE45A
Medical Device Problem Codes	Failure to Fire (2610); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 2/2/2024.D4: batch #: unk.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Is the current patient status known? was there any patient consequence or change in the post-operative care of the patient as a result of the event? (extended hospital stay, readmission, re-operation, etc.) a manufacturing record evaluation was performed for the finished ple45a, with lot/batch number a9c67p, and no non-conformances were identified.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.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 the first stapling, in the making of the y, there was a failure in the stapler, without triggering it.Evidenced a yellow loose part near the safety lock.No patient consequences reported.No further information is available.
Additional Manufacturer Narrative
(b)(4).Date sent: 6/5/2024.D4: batch # 272c77.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 and with a gst45w reload loaded on the device.The reload was received unfired.In addition, the firing trigger switch actuator was received inside of a plastic bag.The device was returned with a non-working firing mechanism.No further functional test could be performed due to the condition of the device.In order to verify the condition of the internal components, the device was disassembled.Upon disassembling, the switch actuator post was found to be broken with the switch actuator loose; which lead to the device not been able to fire.Based on the information currently available, a product issue was identified during the investigation of the sample received.The damage to the actuator post has been correlated to the design.This product issue will be addressed through ethicon endo surgery¿s quality system.Device history review: a manufacturing record evaluation was performed for the finished device batch number 272c77, 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
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 18631149
• Report Number: 3005075853-2024-00974
• Device Sequence Number: 15476934
• 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,Followup
• Report Date (Section B): 06/05/2024

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 Expiration Date: 12/31/2025
• Device Catalogue Number: PLE45A
• Device Lot Number: A9C67P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/08/2024
• Supplement Date Received by Manufacturer: 05/13/2024
• Initial Report FDA Received Date: 02/02/2024
• Supplement Report FDA Received Date: 06/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2023
• 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: Female