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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WICKIMED 20/CA ULTRA NONSTICK 10FT; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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WICKIMED 20/CA ULTRA NONSTICK 10FT; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES Back to Search Results
Catalog Number PLPUL2020
Device Problems Material Discolored (1170); Firing Problem (4011)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/24/2023
Event Type  malfunction  
Event Description
The sales representative reported on behalf of the customer that the plpul2020, 20/ca ultra nonstick 10ft, was being used during a ortho procedure on (b)(6) 2023 when it was reported, ¿plume pen ultra when his pa and the scrub tech started seeing flashes of light within the pen and noticed the electrode coating discolored.They immediately stopped using, and a different devices used.".The procedure was completed with a nominal delay using a different device.There was no report of injury, medical intervention, or hospitalization for the patient.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
 
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 sales representative reported on behalf of the customer that the plpul2020, 20/ca ultra nonstick 10ft, was being used during a ortho procedure on (b)(6) 2023 when it was reported, ¿plume pen ultra when his pa and the scrub tech started seeing flashes of light within the pen and noticed the electrode coating discolored.They immediately stopped using, and a different devices used.".The procedure was completed with a nominal delay using a different device.There was no report of injury, medical intervention, or hospitalization for the patient.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
 
Manufacturer Narrative
Received one plpul2020 in unoriginal packaging.Lot number was not verified.Performed a visual inspection, there is evidence of a burn hole and charring on the bottom side of the body of the pencil.Internally, there is evidence of charring.Performed a functional inspection using the system 7550 (c8406), the cut and coag functions are able to activate as intended.Root cause cannot be determined, however, based upon evaluation of the device; a possible cause of this event could be sparking/arcing.The manufacturing documents from the device history record have not been reviewed because the lot number is not known.A two-year lot history review cannot be conducted as a lot number was not provided.A two-year review of complaint history revealed there has been a total of 9 complaints, regarding 9 devices, for this device family and failure mode.During this same time frame (b)(4) 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 (b)(4).We will continue to monitor for trends through the complaint system to assure patient safety.
 
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Brand Name
20/CA ULTRA NONSTICK 10FT
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
john berga
11311 concept blvd
largo, FL 33773
7273995358
MDR Report Key18064063
MDR Text Key327366188
Report Number1320894-2023-00243
Device Sequence Number1
Product Code GEI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K103375
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/14/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/03/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberPLPUL2020
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received11/28/2023
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Patient Sequence Number1
Patient EthnicityNon Hispanic
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