MAUDE Adverse Event Report: MODERN MEDICAL EQUIPMENT MANUFACTURING LTD. GROUNDING PAD; ELECTROSURGCIAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	88-000202
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Burn(s) (1757); Injury (2348)
Date of Event	08/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: an internal complaint (call (b)(4)) was received indicating that the hydrogel on a grounding pad (part number 88-000202, lot 161206044) had dried up, and therefore, the pad was not sticking to the patient properly.Two incidences of this occurring were reported to deroyal.This is the second incident.In at least one of the two reported occurrences, the absence of hydrogel reported resulted in the patient sustaining burns.The defective item was not returned for evaluation.The complaint investigator reviewed the purchase order for possible discrepancies that may have contributed to the reported event.No discrepancies were documented.The grounding pad is supplied to deroyal by modern medical equipment.The 2015-2017 supplier corrective action request (scar) and supplier notification letter logs were reviewed for similar complaints.Similar complaints were identified.Therefore, a scar was issued to modern medical.As of the date of this report, a response has not been received.Deroyal has sold (b)(4) cases of the finished good between december 17, 2016 and august 17, 2018.Each case contains (b)(4) each, which equates to a total of (b)(4) each sold.Only two complaints with the reported issue were identified, which results in a complaint-to-sales ratio of (b)(4) percent.Deroyal will continue to monitor post market feedback and will recognize in the future if the issue reoccurs.The investigation is ongoing at this time.If new and additional information is received, this report will be updated.
Event or Problem Description
The hydrogel on the grounding pads was dried up.The pads did not stick to the patient properly, and in one incident, this caused burns to the patient.
Additional Manufacturer Narrative
Root cause: because the grounding pad is supplied to deroyal by modern medical, a supplier corrective action request was issued to modern medical for assistance in determining a root cause.Testing of retained samples by the manufacturer found that the stickiness of the hydrogel was within specification.A root cause for the reported failure could not be determined.Corrective action: due to the root cause determination, a corrective action has not been taken.Investigation summary: an internal complaint (call (b)(4)) was received indicating that the hydrogel on a grounding pad (part number 88-000202, lot 161206044) had dried up, and therefore, the pad was not sticking to the patient properly.Two incidences of this occurring were reported to deroyal.This is the second incident.In at least one of the two reported occurrences, the absence of hydrogel reported resulted in the patient sustaining burns.The defective item was not returned for evaluation.The complaint investigator reviewed the purchase order for possible discrepancies that may have contributed to the reported event.No discrepancies were documented.The grounding pad is supplied to deroyal by (b)(4).The 2015-2017 supplier corrective action request (scar) and supplier notification letter logs were reviewed for similar complaints.Similar complaints were identified.Therefore, a scar was issued to (b)(4).A response was received and accepted by deroyal's complaint investigator.In its scar response, (b)(4) stated production records were reviewed and no discrepancies were identified that may have contributed to the reported event.Additionally, retained samples were tested for gel stickiness.All samples tested were within specification.(b)(4).Deroyal will continue to monitor post market feedback and will recognize in the future if the issue reoccurs.The investigation is complete at this time.If new and additional information is received, this report will be updated.
Event or Problem Description
The hydrogel on the grounding pads was dried up.The pads did not stick to the patient properly, and in one incident, this caused burns to the patient.

• Brand Name: GROUNDING PAD
• Common Device Name: ELECTROSURGCIAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MODERN MEDICAL EQUIPMENT MANUFACTURING LTD.; dong xing industrial area; kang le lu, shan xia district; heng li, dongguan guangdong ; CH
• MDR Report Key: 7915520
• Report Number: 1060680-2018-00007
• Device Sequence Number: 2338374
• Product Code: GEI
• UDI-Device Identifier: 00749756142014
• UDI-Public: 00749756142014
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K984276
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2018

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: 88-000202
• Device Lot Number: 161206044
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/29/2018
• Supplement Date Received by Manufacturer: 08/29/2018
• Initial Report FDA Received Date: 09/27/2018
• Supplement Report FDA Received Date: 10/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1