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

Model Number	EPH04
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unknown.The account provided 1 video.The video provided by the account is that of an eph04 instrument where it can be seen that the device was suction without pressing the button.Because the instrument was not return our evaluation is limited.Therefore, no conclusion could be reached as to the root cause of the reported issue.We value the opportunity to fully analyze the instrument upon its return.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.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.Additional information was requested, and the following was obtained: did the patient experience any adverse consequences due to this issue? unknown.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 procedure the suction was activated without pressing button.It is unknown if the patient had any consequences.
Additional Manufacturer Narrative
(b)(4).Date sent: 9/1/2020.Investigation summary: the device was received with no apparent damage.The device was tested for continuity and no continuous activation was found as reported.In addition, the device was leak tested and a leak was found at the suction, irrigation and distal shaft test.The device was disassembled to inspect internal component and it was observed that the suction and irrigation button were not detached from the stem valve.Upon visual inspection under magnification, it was observed that the button stem was a broken across valve section.A manufacturing record evaluation was performed for the finished device and the manufacturing criteria were met prior to the release of this lot/batch.The leak issue reported by the customer is confirmed.No conclusion could be reached as to the cause of the leak.It should be noted that as part of our quality process all devices are manufactured, inspected, and released to approved specifications.

• Common Device Name: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 10448729
• Report Number: 3005075853-2020-04310
• Device Sequence Number: 3656471
• Product Code: GCJ
• UDI-Device Identifier: 10705036001874
• UDI-Public: 10705036001874
• 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): 08/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2024
• Device Model Number: EPH04
• Device Catalogue Number: EPH04
• Device Lot Number: T9433Z
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2020
• Initial Date Received by Manufacturer: 08/03/2020
• Supplement Date Received by Manufacturer: 08/27/2020
• Initial Report FDA Received Date: 08/25/2020
• Supplement Report FDA Received Date: 09/01/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR