MAUDE Adverse Event Report: WIKIMED MEDICAL EQUIPMENT MANUFACTURING CO. LTD 20/CA PLUMEPEN PRO NONSTICK(S); ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	PLPRO4520
Medical Device Problem Codes	Overheating of Device (1437); Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2022
Type of Reportable Event	Malfunction
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.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer that the device, plpro4520, 20/ca plumepen pro nonstick(s) was being used during a laparoscopic sigmoid resection procedure on (b)(6) 2022 when it was reported ¿coag button delayed when activated/ overheated and burnt hole in drape.¿ after further assessment it was found that the patient did not obtain a burn.It was also reported that there was a five-minute delay in the procedure.The procedure was completed with the use of an unknown alternate device and there was no report of injury, medical intervention or hospitalization to patient or user.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Received one plpro4520 in opened original package.Lot number was verified.Performed a visual inspection, there were evidence of burns on the tip of the electrode.No problems were found and the device functioned as intended.The device is not manufactured by conmed.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 (b)(4) complaints, regarding 23 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).Per the ifu, the user is advised that the electrode tip may remain hot enough to cause burns after the current has been de-activated.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer that the device, plpro4520, 20/ca plumepen pro nonstick(s) was being used during a laparoscopic sigmoid resection procedure on (b)(6) 2022 when it was reported ¿coag button delayed when activated/ overheated and burnt hole in drape.¿ after further assessment it was found that the patient did not obtain a burn.It was also reported that there was a five-minute delay in the procedure.The procedure was completed with the use of an unknown alternate device and there was no report of injury, medical intervention or hospitalization to patient or user.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: 20/CA PLUMEPEN PRO NONSTICK(S)
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): WIKIMED MEDICAL EQUIPMENT MANUFACTURING CO. LTD; 4-5/f, building b; tangjiao industrial area; lilin, huizhou, prc china 51600 0; CH 516000
• Manufacturer (Section G): WIKIMED MEDICAL EQUIPMENT MANUFACTURING CO. LTD; 4-5/f building b; tangjiao industrial area; lilin, huizhou, prc china 51600 0; CH 516000
• Manufacturer Contact: samantha dewberry ; 525 french rd; utica, NY 13502 ; 3152230184
• MDR Report Key: 14957506
• Report Number: 1320894-2022-00144
• Device Sequence Number: 5459286
• Product Code: GEI
• UDI-Device Identifier: 20845854061203
• UDI-Public: (01)20845854061203(17)240301(10)320221
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K103375
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2022

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: 03/01/2024
• Device Model Number: PLPRO4520
• Device Catalogue Number: PLPRO4520
• Device Lot Number: 320221
• 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: 06/15/2022
• Supplement Date Received by Manufacturer: 09/06/2022
• Initial Report FDA Received Date: 07/08/2022
• Supplement Report FDA Received Date: 09/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic