MAUDE Adverse Event Report: MODERN MEDICAL EQUIP MFG LTD SUCTION COAG, F/S, 10FR, 25/CS; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number 130187

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 12/14/2023

Event Type  Injury  

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 distributor reported on behalf of their customer that the 130187, suction coag, f/s, 10fr, 25/cs, was being used during an unknown procedure on (b)(6) 2023 when it was reported, ¿¿.The burn caused by the conmed suction coagulator.In order to see the defect i had to use our lighted magnifying glass from our spd department.In picture i show when the malleable tip was bent and on the under surface is a tiny window where there is no insulation.¿ there was no report of medical intervention or hospitalization for the patient or user.Further assessment questions were sent to the reporter; however, to date there has not been a response.This report is being raised due to the reported injury of unknown degree of burn to patient.

Manufacturer Narrative

Reported event of burn to patient is confirmed based on photographic evidence provided.Received one 130187 in opened original package.Lot number was verified.Performed a visual inspection and there was no visual abnormalities to the insulation of the handpiece.Root cause cannot be determined, however, based upon ifu; a possible cause of this event could be using a higher recommended setting than what was needed.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.This is the only complaint for this lot number and failure mode within the past two years.(b)(4).Per the instructions for use, the user is advised the following: use lowest possible power setting on the associated electrosurgical unit capable of achieving desired surgical effect.Activation time should be as short as possible.Do not directly secure the cable with metal instruments to surgical drapes.Activation when in contact with metal instruments may cause burns at the tissue / instrument interface.To avoid burns never allow cable associated with this device to be in contact with skin of patient or touching operator do not permit the cables connected to these devices to be parallel and in close proximity to the leads of other electrical devices.We will continue to monitor for trends through the complaint system to assure patient safety.

Event Description

The distributor reported on behalf of their customer that the 130187, suction coag, f/s, 10fr, 25/cs, was being used during an unknown procedure on (b)(6) 2023 when it was reported, "the burn caused by the conmed suction coagulator.In order to see the defect i had to use our lighted magnifying glass from our spd department.In picture i show when the malleable tip was bent and on the under surface is a tiny window where there is no insulation." there was no report of medical intervention or hospitalization for the patient or user.Further assessment questions were sent to the reporter; however, to date there has not been a response.This report is being raised due to the reported injury of unknown degree of burn to patient.Updated reporter information: (b)(6) 2024, surgery, tonsillectomy/adenoidectomy, the procedure was completed.Surgeon use a valleylab force fx for cautery.The surgeon has the cut at 8 and the coag at 10.Burn was observed prior to surgery completion.Antibiotic ointment applied and given to patient to use.The user had bent the tip prior to use.

• Brand Name: SUCTION COAG, F/S, 10FR, 25/CS
• Type of Device: 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: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 18491229
• MDR Text Key: 332611649
• Report Number: 3007305485-2024-00008
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: RP
• PMA/PMN Number: K033003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/28/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 130187
• Device Lot Number: 202309044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2023
• Initial Date FDA Received: 01/11/2024
• Supplement Dates Manufacturer Received: 02/27/2024
• Supplement Dates FDA Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2023
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Treatment: VALLEYLAB FORCE FX
• Patient Outcome(s): Other
• Patient Age: 4 YR
• Patient Sex: Male
• Patient Weight: 21 KG
• Patient Ethnicity: Non Hispanic