MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPATH*PROBE PLUS II HANDLE; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number	EPH04
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown procedure there was poor connection.Not working.No patient consequences reported when this complaint event occurred.
Additional Manufacturer Narrative
(b)(4).Date sent: 5/22/2025.D4 batch #: c9dd5l.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 the device was received with no apparent damage and with body fluids present.The device was mechanically tested and no issues were found.Upon testing the coagulation button the device stays on after releasing the button; resulting in continuous activation.The device was disassembled to evaluate the internal components the wire assembly of the two wires were found to be pinched; causing continuous activation.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.It is possible that damage to the internal cable could occur during our manufacturing process.Based on the information currently available, a product issue was identified during the investigation of the sample received.This product issue will be addressed through the quality system.
Additional Manufacturer Narrative
(b)(4).Date sent: 5/27/2025 d4 batch #: c9da6u a manufacturing record evaluation was performed for the finished device batch c9da6u, and no non-conformances were identified.
Additional Manufacturer Narrative
(b)(4).Date sent: 6/12/2025 corrected data: h6 type of investigation, h11 investigation summary.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 the device was received with no apparent damage and with body fluids present.The device was mechanically tested and no issues were found.The device was connected to a multi tester to test the switch function.The coagulation mode was noted to be on as soon as the device was connected to the multi tester.The cut function worked as intended the device was disassembled to evaluate the internal components the wire assembly of the two wires were found to be pinched; causing continuous activation.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.It is possible that damage to the internal cable could occur during our manufacturing process.Based on the information currently available, a product issue was identified during the investigation of the sample received.This product issue will be addressed through the quality system.A manufacturing record evaluation was performed for the finished device batch c9da6u, and no non-conformances were identified.

• Common Device Name: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• 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: orla o'mahony ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 22070723
• Report Number: 3005075853-2025-03868
• Device Sequence Number: 9337719
• Product Code: GCJ
• UDI-Device Identifier: 10705036001874
• UDI-Public: (01)10705036001874(17)281231(10)C9DD5L
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K912492
• 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,Followup
• Report Date (Section B): 05/22/2025

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: EPH04
• Device Lot Number: C9DD5L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/21/2025
• Supplement Date Received by Manufacturer: 05/22/2025; 06/10/2025
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 05/27/2025; 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2024
• 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: GENERATOR.
• Patient Sex: Unknown