MAUDE Adverse Event Report: WICKIMED PLUMEPEN ELITE SURGICAL SMOKE EVAC PENCIL, 10FT TUBING,QTY20; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	PLP2020
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/26/2024
Type of Reportable Event	Serious Injury
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 received.
Event or Problem Description
The customer reported that the device, plp2020, plumepen elite surgical smoke evac pencil, 10ft tubing,qty20, was being used on (b)(6) 2024 and ¿one of the clear plastic plume tubes fell off the device while the scrub nurse was preparing it prior to surgery.The team opened another one which she checked and it appeared to be¿.Per further assessment it was found that "the team opened another one which she checked and it appeared to be fine.During surgery the surgeon alerted the scrub nurse that the diathermy had fallen apart, the clear plastic tube had come away from the main body and one of the collars was missing.The broken device was replaced to complete the surgery.It was replaced by the same type of device with the same lot.There were no problems with this device." it was also found that "after several hours of operating the device fell apart in the surgeons hands." it is unknown if the fragment fell into the patient "the surgical wound was searched thoroughly, the swabs, drapes and floor were all searched but the piece of plastic was not found.The piece in question was clear in colour and approximately 2mm in size.The wound was a large midline laparotomy wound.Every effort was made to find the missing piece.It was not radio-opaque and too small to show on an x-ray.It is unknown if the piece fell into the surgical wound or not.User was not injured.Any possible post-operative complaints/complications from the patient are still to be assessed/determined." there was no prolonged hospitalization due to this event and there was a 30 minute delay to the procedure.This report is being raised on the reported injury due to possibility of a foreign body remaining inside of the patient.
Event or Problem Description
The customer reported that the device, plp2020, plumepen elite surgical smoke evac pencil, 10ft tubing, qty (b)(4), was being used on (b)(6) 2024 and ¿one of the clear plastic plume tubes fell off the device while the scrub nurse was preparing it prior to surgery.The team opened another one which she checked and it appeared to be¿.Per further assessment it was found that "the team opened another one which she checked and it appeared to be fine.During surgery the surgeon alerted the scrub nurse that the diathermy had fallen apart, the clear plastic tube had come away from the main body and one of the collars was missing.The broken device was replaced to complete the surgery.It was replaced by the same type of device with the same lot.There were no problems with this device." it was also found that "after several hours of operating the device fell apart in the surgeons hands." it is unknown if the fragment fell into the patient "the surgical wound was searched thoroughly, the swabs, drapes and floor were all searched but the piece of plastic was not found.The piece in question was clear in colour and approximately 2mm in size.The wound was a large midline laparotomy wound.Every effort was made to find the missing piece.It was not radio-opaque and too small to show on an x-ray.It is unknown if the piece fell into the surgical wound or not.User was not injured.Any possible post-operative complaints/complications from the patient are still to be assessed/determined." there was no prolonged hospitalization due to this event and there was a 30 minute delay to the procedure.This report is being raised on the reported injury due to possibility of a foreign body remaining inside of the patient.
Additional Manufacturer Narrative
The device is not being returned and the photographic evidence provided does not appear to verify the complaint; therefore, a device malfunction cannot be verified.A two-year lot history review shows a total of 15 devices for this lot number and failure mode.A device history record (dhr) review was requested from the manufacturer, and no indication of abnormalities was communicated.(b)(4).We will continue to monitor for trends through the complaint system to assure patient safety.
Additional Manufacturer Narrative
Received fifteen plp2020 in unopened original packaging.Lot number was verified.Performed a visual inspection, there were no obvious signs of abnormalities or defects.The tubing is connected to the devices as intended.A two-year lot history review shows a total of 15 devices for this lot number and failure mode.A device history record (dhr) review was requested from the manufacturer, and no indication of abnormalities was communicated.A two-year review of complaint history revealed there has been a total of 5 reports, regarding 23 devices, for this device family and failure mode.During this same time frame 4,346,790 devices 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 0.000005.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, plp2020, plumepen elite surgical smoke evac pencil, 10ft tubing,qty20, was being used on (b)(6) 2024 and ¿one of the clear plastic plume tubes fell off the device while the scrub nurse was preparing it prior to surgery.The team opened another one which she checked and it appeared to be¿.Per further assessment it was found that "the team opened another one which she checked and it appeared to be be fine.During surgery the surgeon alerted the scrub nurse that the diathermy had fallen apart, the clear plastic tube had come away from the main body and one of the collars was missing.The broken device was replaced to complete the surgery.It was replaced by the same type of device with the same lot.There were no problems with this device." it was also found that "after several hours of operating the device fell apart in the surgeons hands." it is unknown if the fragment fell into the patient "the surgical wound was searched thoroughly, the swabs, drapes and floor were all searched but the piece of plastic was not found.The piece in question was clear in colour and approximately 2mm in size.The wound was a large midline laparotomy wound.Every effort was made to find the missing piece.It was not radio-opaque and too small to show on an x-ray.It is unknown if the piece fell into the surgical wound or not.User was not injured.Any possible post-operative complaints/complications from the patient are still to be assessed/determined." there was no prolonged hospitalization due to this event and there was a 30 minute delay to the procedure.This report is being raised on the reported injury due to possibility of a foreign body remaining inside of the patient.

• Brand Name: PLUMEPEN ELITE SURGICAL SMOKE EVAC PENCIL, 10FT TUBING,QTY20
• 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: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 18920366
• Report Number: 1320894-2024-00066
• Device Sequence Number: 7505574
• Product Code: GEI
• UDI-Device Identifier: 10845854061282
• UDI-Public: (01)10845854061282(17)260313(10)WM20230308
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K230547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/08/2024

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: 03/13/2026
• Device Catalogue Number: PLP2020
• Device Lot Number: WM20230308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2024
• Supplement Date Received by Manufacturer: 04/29/2024; 10/01/2024
• Initial Report FDA Received Date: 03/18/2024
• Supplement Report FDA Received Date: 04/30/2024; 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2023
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic