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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MODERN MEDICAL EQUIPMENT MANUFACTURING LTD. 1" BLADE ELECTRODE ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)

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MODERN MEDICAL EQUIPMENT MANUFACTURING LTD. 1" BLADE ELECTRODE ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES) Back to Search Results
Model Number 88-000M13C
Device Problems Melted (1385); Material Deformation (2976); Material Integrity Problem (2978)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/24/2017
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: an internal complaint ((b)(4)) was received indicating a 1" blade electrode melted during use. No patient harm was reported. On february 23, 2017, deroyal received notice of a medwatch report from the fda. This medwatch is related to the incident reported in 1060680-2017-00008. During a review of complaints, this report was found to be related. A sample initially was reported to be available. As of the date of this report, the sample has not been received. The electrode is supplied to deroyal by (b)(4). Therefore, a supplier corrective action request was submitted february 22, 2017, to modern medical. As of the date of this report, a response has not been received. This report has not been submitted within the 30 days required. This is due to an employee error. The investigation is incomplete at this time. When new and critical information becomes available, this report will be updated.
 
Event Description
Insulated coated electrode blades melted during use. The settings were set at coag 40/cut 40. There was no apparent harm to the patient. The device was in use with a cautery machine.
 
Manufacturer Narrative
Root cause: the electrode is supplied to deroyal by (b)(4). Therefore, a supplier corrective action request (scar) was submitted to (b)(4). In its response, (b)(4) review and tested retained samples and observed no melting on the insulated tube or electrode tip. Therefore, the root cause is unable to be determined. Corrective action: in its scar response, (b)(4) stated if the defective samples or additional information is received, further analysis will be taken. Investigation summary: an internal complaint ((b)(4)) was received indicating a 1" blade electrode melted during use. No patient harm was reported. On february 23, 2017, deroyal received notice of a medwatch report from the fda. This medwatch report is related to the incident reported in 1060680-2017-00008. During a review of complaints, this report was found to be related. A sample initially was reported to be available. As of the date of this report, the sample has not been received. A deroyal sales representative has been in contact with the reporting customer, and if the sample is received, the complaint investigation will be reopened. The work order for the reported lot number was reviewed for discrepancies that may have contributed to the reported event. No discrepancies were identified. A scar was issued to (b)(4) and a response received march 3. Deroyal quality personnel has reviewed and accepted the response. In its response, (b)(4) stated four samples from two lots were tested using a bovie generator at power setting 40 for 10 cycles (one cycle is 10 seconds for cut mode and 10 seconds for coagulation mode). All samples passed without any melting occurring on the insulated tube or the electrode tip. Preventive action: a preventive action has not been taken. The investigation is complete at this time. If new and critical information is received, this report will be updated.
 
Event Description
Insulated coated electrode blades melted during use. The settings were set at coag 40/cut 40. There was no apparent harm to the patient. The device was in use with a cautery machine.
 
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Brand Name1" BLADE ELECTRODE
Type of DeviceELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)
Manufacturer (Section D)
MODERN MEDICAL EQUIPMENT MANUFACTURING LTD.
dong xing industrial area
kang le lu, shan xia district
heng li, dongguan guangdong 52346 6
CH 523466
Manufacturer (Section G)
DEROYAL INDUSTRIES, INC.
1703 highway 33 south
new tazewell TN 37825
Manufacturer Contact
sarah bennett
200 debusk lane
powell, TN 37849
8653626112
MDR Report Key6372274
MDR Text Key68851466
Report Number1060680-2017-00009
Device Sequence Number1
Product Code HGI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K952030
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/21/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/02/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number88-000M13C
Device Lot Number41057548
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/02/2017
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

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