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

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. 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 (b)(4). As of the date of this report, a response has not been received. The investigation is incomplete at this time. When new and critical information becomes available, this report will be updated.

Event Description

Insulated coated electrocautery 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 modern medical. Therefore, a supplier corrective action request (scar) was submitted to modern medical. In its response, modern medical 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, modern medical stated if the defective samples or additional information is received, further analysis will be taken. Investigation summary an internal complaint (call (b)(6)) 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. 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 modern medical and a response received march 3. Deroyal quality personnel has reviewed and accepted the response. In its response, modern medical 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 electrocautery 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.

• Brand Name: 1" BLADE ELECTRODE
• Type of Device: ELECTROCAUTERY, 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 Key: 6372272
• MDR Text Key: 69169188
• Report Number: 1060680-2017-00008
• Device Sequence Number: 1
• Product Code: HGI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K952030
• Number of Events Reported: 1
• 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 Received: 03/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 88-000M13C
• Device Lot Number: 43105398
• 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 Received: 02/02/2017
• 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