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

Catalog Number PLP2020

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/26/2024

Event Type  Injury  

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 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 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.

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.

• Brand Name: PLUMEPEN ELITE SURGICAL SMOKE EVAC PENCIL, 10FT TUBING,QTY20
• Type of Device: 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
• MDR Text Key: 337851931
• Report Number: 1320894-2024-00066
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10845854061282
• UDI-Public: (01)10845854061282(17)260313(10)WM20230308
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K230547
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PLP2020
• Device Lot Number: WM20230308
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Ethnicity: Non Hispanic