MAUDE Adverse Event Report: MODERN MEDICAL EQUIPMENT MANUFACTURING LTD. ELECTRODE, BLADE 1" COATED; ELECTROCAUTERY, GYNECOLOGIC

Model Number	88-000M13C
Medical Device Problem Codes	Melted (1385); Material Deformation (2976); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: an internal complaint (b)(4)was received for an electrode (part 88-000m13c, lot 44748512) stating that the sheath of the blade melted during use.A defective sample initially was reported to be available for return.However, as of the date of this report, that sample has not been returned for evaluation.The complaint investigator reviewed the work order for possible discrepancies that may have contributed to the reported event.No discrepancies were identified.Lot mapping identified that the raw material electrode is supplied to deroyal by modern medical equipment.The 2016-2018 supplier corrective action request (scar) and supplier notification letter logs were reviewed for similar complaints.Similar complaints were identified, and a scar was issued to modern medical.As of the date of this report, a response has not been received.Between january 2017 and april 2019, deroyal has sold 1,051 cases of the finished good.Five similar complaints were identified.This is a complaint-to-sales ratio of 0.004757 or 0.476%.The investigation is ongoing at this time.When new and critical information is received, this report will be updated.
Event or Problem Description
The sheath of the electrode blade melted two separate times during separate surgeries.
Additional Manufacturer Narrative
Root cause: the electrode is supplied to deroyal by modern medical equipment.Therefore, a supplier corrective action request (scar) as well as returned samples were sent to modern medical for evaluation.The supplier performed testing on retained and returned samples and was unable to repeat the reported failure.All samples performed well and met specification.In its scar response, modern medical stated it was unable to confirm the complaint and therefore determine a root cause.The possible root cause may be a mechanical puncture of the blade sheath when the sheath is stretched to cover the tip.Corrective action: in its scar response, modern medical stated it was unable to confirm the reported issue and determine a root cause.Therefore, no corrective action has been taken.Investigation summary an internal complaint (b)(4) was received for an electrode (part 88-000m13c, lot 44748512) stating that the sheath of the blade melted during use.A defective sample initially was reported to be available for return.One returned sample was received may 1, 2019 and shipped to the supplier for evaluation.The complaint investigator reviewed the work order for possible discrepancies that may have contributed to the reported event.No discrepancies were identified.Lot mapping identified that the raw material electrode is supplied to deroyal by modern medical equipment.The 2016-2018 supplier corrective action request (scar) and supplier notification letter logs were reviewed for similar complaints.Similar complaints were identified, and a scar was issued to modern medical.A response was received and accepted june 6, 2019, by deroyal personnel.Between january 2017 and april 2019, deroyal has sold (b)(4) cases of the finished good.Five similar complaints were identified.This is a complaint-to-sales ratio of (b)(4).The investigation is complete at this time.If new and critical information is received, this report will be updated.
Event or Problem Description
The sheath of the electrode blade melted two separate times during separate surgeries.

• Brand Name: ELECTRODE, BLADE 1" COATED
• Common Device Name: ELECTROCAUTERY, GYNECOLOGIC
• Manufacturer (Section D): MODERN MEDICAL EQUIPMENT MANUFACTURING LTD.; dong xing industrial area; kang le lu, shan xia district; heng li, dongguan, 52346 6; CH 523466
• MDR Report Key: 8617653
• Report Number: 1060680-2019-00007
• Device Sequence Number: 2039354
• Product Code: HGI
• UDI-Device Identifier: 50749756136018
• UDI-Public: 50749756136018
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K952030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2019

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 Model Number: 88-000M13C
• Device Lot Number: 44748512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2019
• Initial Date Received by Manufacturer: 04/16/2019
• Supplement Date Received by Manufacturer: 04/16/2019
• Initial Report FDA Received Date: 05/16/2019
• Supplement Report FDA Received Date: 08/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1