MAUDE Adverse Event Report: MODERN MEDICAL EQUIP MFG LTD PLUMEPEN; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	PLP1020
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A sales representative reported on behalf of a customer that the plp1020, 20/ca plumepen elite (s) device was being used on (b)(6) 2024, and ¿button is stuck in "on" position, won't turn off.¿.Follow-up assessment was attempted but upon response, the customer provided no further information; therefore, it could not be determined if this was an event of self-activation and whether it occurred intra-operatively or during pre-operative testing.There was no report of injury, medical/surgical intervention, or hospitalization for the user.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
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.Device not yet received.
Additional Manufacturer Narrative
Received one plp1020 in opened original packaging.Lot number was verified.Performed a visual inspection, externally there were no obvious signs of abnormalities or defects.Internally, the coagulation button was concaved making continuous contact with the circuit board.Performed a functional inspection using the esu system 7550 (c8406), the coagulation continuously self activates.The root cause cannot be determined, however, based upon evaluation with photos, the likely cause of this event was excessive force to the button.A two-year lot history review shows a total of 1 device for this lot number and failure mode.A device history review (dhr) 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 41 reports, regarding 60 devices, for this device family and failure mode.During this same time frame 4,487,235 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 0.00001.Per the instructions for use, the user is advised: inspect instruments and cables for damage prior to each use, especially the insulation of laparoscopic/endoscopic instruments.This may be done visually under magnification or with a high voltage insulation testing device.Insulation failures may result in burns or other injuries to the patient or operator.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 plp1020, 20/ca plumepen elite (s) device was being used on 09aug24, and ¿button is stuck in "on" position, won't turn off.¿.Follow-up assessment was attempted but upon response, the customer provided no further information; therefore, it could not be determined if this was an event of self-activation and whether it occurred intra-operatively or during pre-operative testing.There was no report of injury, medical/surgical intervention, or hospitalization for the user.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: PLUMEPEN
• 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: 20147670
• Report Number: 1320894-2024-00225
• Device Sequence Number: 4248473
• Product Code: GEI
• UDI-Device Identifier: 10845854061268
• UDI-Public: (01)10845854061268(17)251030(10)MM20221019
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2024

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: 10/30/2025
• Device Catalogue Number: PLP1020
• Device Lot Number: MM20221019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2024
• Supplement Date Received by Manufacturer: 10/17/2024
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic