MAUDE Adverse Event Report: WICKIMED INTEGRATED SMOKE EVACUATION PENCIL; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	ORVPLP02
Medical Device Problem Code	Self-Activation or Keying (1557)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.We will continue to monitor for trends through the complaint system to assure patient safety.H3 other text : device not yet returned.
Event or Problem Description
The customer reported that the device, orvplp02, integrated smoke evacuation pencil, was being used during an unknown procedure on (b)(6) 2023 when it was reported, ¿the console showed power being given out.And orvac activated automatically.¿.There was no initial report of injury, medical intervention, or hospitalization for the patient or user.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Received one (b)(6) in unoriginal packaging.Lot number was not verified.Performed a visual inspection, there were no obvious signs of abnormalities or defects.Performed a functional inspection using the esu system 7550 ((b)(6)), the device functioned as intended.A device history record review was requested from the manufacturer and no indication of abnormalities was communicated.A 2 year lot history review shows a total of(b)(4) for this lot number and failure mode however, none are confirmed.A two-year review of complaint history revealed there has been a total of (b)(4), regarding 4 devices, for this device family and failure mode.During this same time frame(b)(4)have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4).Per the instructions for use, the user is advised that inadvertent activation or movement of the activated electrode outside of the field of vision may result in injury to the patient.When not in use, the active electrode should be placed in a clean, dry, non-conductive safety holster.Integrated smoke evacuation pencil is designed and intended only to be used with an electrosurgical generator that has been tested to the iec 60601 standard.Please refer to generator to ensure compatibility.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
The customer reported that the device, (b)(6), integrated smoke evacuation pencil, was being used during an unknown procedure on (b)(6) 2023 when it was reported, ¿the console showed power being given out.And orvac activated automatically.¿.There was no initial report of injury, medical intervention, or hospitalization for the patient or user.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

• Brand Name: INTEGRATED SMOKE EVACUATION PENCIL
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): WICKIMED; 4-5/f, building b; tangjiao industrial area; lilin, huizhou, prc 51600 0; CH 516000
• Manufacturer (Section G): WICKIMED; 4-5/f, building b; tangjiao industrial area; lilin, huizhou, prc 51600 0; CH 516000
• Manufacturer Contact: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 17441349
• Report Number: 1320894-2023-00148
• Device Sequence Number: 16821910
• Product Code: GEI
• UDI-Device Identifier: 10845854082065
• UDI-Public: (01)10845854082065(17)260207(10)110223
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K103375
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2023

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: 02/07/2026
• Device Catalogue Number: ORVPLP02
• Device Lot Number: 110223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2023
• Supplement Date Received by Manufacturer: 09/14/2023
• Initial Report FDA Received Date: 08/02/2023
• Supplement Report FDA Received Date: 09/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic