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

Model Number	EPS07
Medical Device Problem Code	Arcing of Electrodes (2289)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).No lot or batch number was provided therefore a device history could not be done.Additional information was requested, and the following was obtained: eps05 => eps07.The device became not to activate after the device was used for 10 minutes, although the device had been activated properly before use.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 during a laparoscopic ob-gyn procedure, the device became not to activate after the device was used for 10 minutes.Another device was used to complete the case.There were no adverse consequences to the patient.One device will be returning.
Additional Manufacturer Narrative
(b)(4).Date sent: 11/18/2020 the instrument was received with the electrode tip bent and the shaft sheath damaged at the instrument tip.A bent electrode could have caused this damage to the sheath.Caution should be taken not to retract the electrode into the sheath when it is bent.Due to condition of the device we were unable to investigated further the cautery issues as reported.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.No conclusion could be reached as to how the tip of the electrode got bent.

• Common Device Name: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 10844385
• Report Number: 3005075853-2020-06033
• Device Sequence Number: 11673617
• Product Code: GCJ
• UDI-Device Identifier: 10705036012511
• UDI-Public: 10705036012511
• 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): 10/23/2020

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: 05/31/2025
• Device Model Number: EPS07
• Device Catalogue Number: EPS07
• Device Lot Number: U94D5L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2020
• Initial Date Received by Manufacturer: 10/23/2020
• Supplement Date Received by Manufacturer: 11/13/2020
• Initial Report FDA Received Date: 11/16/2020
• Supplement Report FDA Received Date: 11/18/2020
• Patient Sequence Number: 1