MAUDE Adverse Event Report: MODERN MEDICAL EQUIPMENT CO. 20/CA PLUMEPEN ELITE (S); ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number PLP1020

Device Problem Excessive Heating (4030)

Patient Problem Burn(s) (1757)

Event Date 12/08/2021

Event Type  Injury  

Event Description

The sales representative reported on behalf of the customer that the plp1020, 20/ca plumepen elite (s), was being during a breast surgery on (b)(6) 2021 when it was reported, ¿patient had small minor burn during breast surgery from plume pen elite pencil.¿ there was no report of injury, medical intervention, or hospitalization for the patient.Further assessment questioning found that the degree of burn is unknown.The burn occurred during the creation of flaps.No intervention was reported.The patient recovered with no issues.The procedure was completed with a 2-minute delay.This report is being raised on the basis of injury due to unknown degree of burn.

Manufacturer Narrative

The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The sales representative reported on behalf of the customer that the plp1020, 20/ca plumepen elite (s), was being during a breast surgery on (b)(6) 2021 when it was reported, ¿patient had small minor burn during breast surgery from plume pen elite pencil.¿ there was no report of injury, medical intervention, or hospitalization for the patient.Further assessment questioning found that the degree of burn is unknown.The burn occurred during the creation of flaps.No intervention was reported.The patient recovered with no issues.The procedure was completed with a 2-minute delay.This report is being raised on the basis of injury due to unknown degree of burn.

Manufacturer Narrative

The device is not being returned and no photograph evidence was provided.Therefore, the reported failure could not be verified.The manufacturing documents from the device history record have not been reviewed because the lot number is not known.The lot history was not reviewed because the lot number is not known.(b)(4).This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: 20/CA PLUMEPEN ELITE (S)
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MODERN MEDICAL EQUIPMENT CO.; unit a, 11/f.mai wah ind bldg; 1-7 wah sing street; kwai chung, nt ; HK
• Manufacturer (Section G): MODERN MEDICAL EQUIPMENT CO.; unit a, 11/f.mai wah ind bldg; 1-7 wah sing street; kwai chung, nt ; HK
• Manufacturer Contact: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 13151609
• MDR Text Key: 285012528
• Report Number: 1320894-2022-00001
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103375
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/21/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: PLP1020
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2021
• Initial Date FDA Received: 01/04/2022
• Supplement Dates Manufacturer Received: 01/07/2022
• Supplement Dates FDA Received: 01/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic