MAUDE Adverse Event Report: MODERN MEDICAL EQUIP MFG LTD PLUMEPEN ELITE SURGICAL SMOKE EVAC PENCIL, 15FT TUBING,QTY20; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	PLP2520
Medical Device Problem Code	Self-Activation or Keying (1557)
Health Effect - Clinical Codes	Laceration(s) (1946); Partial thickness (Second Degree) Burn (2694)
Date of Event	04/11/2024
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
A sales representative reported on behalf of a customer that the plp2520, plumepen elite surgical smoke evac pencil, 15ft tubing,qty20 device was being used during an insertion spinal cord stimulator procedure on (b)(6) 2024, and ¿pencil was not actively being used, was sitting on sterile field.Surgeon was burned by pencil through gown, cutting/burning arm.No sound from cautery machine noted.Pencil was out of side pack¿.Follow-up assessment found the user had sustained a "2nd degree burn as well as a cut" to the right forearm, and that the device "had been used (activated) and was set down not currently in use".The customer opined that the device "apparently" self-activated, as "plenty of time passed for it to cool down".The procedure was completed with regular cautery and no delay.It was confirmed that "no intervention or hospitalization was required.They did draw a hiv and hepatitis panel from the patient per our policy.".This report is being raised due to the reported injury of a second degree burn and laceration to the user.
Additional Manufacturer Narrative
Received one plp2520 unoriginal package.Lot number was not verified.Performed a visual inspection, no abnormalities or defects were confirmed.Performed a functional inspection using the esu system 7550, the coag button was very sensitive to palpitation and activated intermittently.Upon further evaluation of the inside components of the electrical pad, corrosion was evident.The root cause cannot be determined, however, based upon evaluation and photos, the likely cause of this event was water ingress into the circuit board.A device history review (dhr) was requested from the manufacturer, and no indication of abnormalities was communicated.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of 87 reports, regarding 135 devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.(b)(4).We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
A sales representative reported on behalf of a customer that the plp2520, plumepen elite surgical smoke evac pencil, 15ft tubing,qty20 device was being used during an insertion spinal cord stimulator procedure on (b)(6) 2024, and ¿pencil was not actively being used, was sitting on sterile field.Surgeon was burned by pencil through gown, cutting/burning arm.No sound from cautery machine noted.Pencil was out of side pack¿.Follow-up assessment found the user had sustained a "2nd degree burn as well as a cut" to the right forearm, and that the device "had been used (activated) and was set down not currently in use".The customer opined that the device "apparently" self-activated, as "plenty of time passed for it to cool down".The procedure was completed with regular cautery and no delay.It was confirmed that "no intervention or hospitalization was required.They did draw a hiv and hepatitis panel from the patient per our policy.".This report is being raised due to the reported injury of a second degree burn and laceration to the user.

• Brand Name: PLUMEPEN ELITE SURGICAL SMOKE EVAC PENCIL, 15FT TUBING,QTY20
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MODERN MEDICAL EQUIP MFG LTD; unit a, 10/f mai wah ind bldg; 1-7 wah sing street; kwai chung, nt ; HK
• Manufacturer (Section G): MODERN MEDICAL EQUIP MFG LTD; unit a, 10/f mai wah ind bldg; 1-7 wah sing street; kwai chung, nt ; HK
• Manufacturer Contact: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 19220910
• Report Number: 1320894-2024-00117
• Device Sequence Number: 20881511
• Product Code: GEI
• UDI-Device Identifier: 10845854061305
• UDI-Public: (01)10845854061305(17)250625(10)MM20220688
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K230547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2024

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: 06/26/2025
• Device Catalogue Number: PLP2520
• Device Lot Number: MM20220688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2024
• Supplement Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 05/01/2024
• Supplement Report FDA Received Date: 06/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic