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

Catalog Number	EPH02
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #: unk.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.The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.
Event or Problem Description
It was reported that before an unknown procedure, the coagulation button was activated although the coagulation button was not pressed when the device was connected to a generator.The generator was replaced to another one, but the same event occurred.The device was not used for the patient.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.
Additional Manufacturer Narrative
(b)(4).Investigation summary: the device was returned with no apparent damage and with body fluids present.The device was mechanically tested and no issues were found.Upon testing the energy 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.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.It is possible that this issue could occur during our manufacturing process.

• Common Device Name: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 9246600
• Report Number: 3005075853-2019-23015
• Device Sequence Number: 10877610
• Product Code: GCJ
• UDI-Device Identifier: 10705036012443
• UDI-Public: 10705036012443
• Combination Product (Y/N): N
• PMA/510(K) Number: K912492
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2019

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: 05/31/2024
• Device Catalogue Number: EPH02
• Device Lot Number: T93R8N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2019
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 12/11/2019
• Initial Report FDA Received Date: 10/28/2019
• Supplement Report FDA Received Date: 01/07/2020
• Patient Sequence Number: 1