MAUDE Adverse Event Report: CATHAY MANUFACTURING CORP. GROUNDING PAD, ADULT; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	88-000102
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Grounding Malfunction (1271); Unintended Electrical Shock (4018)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: an internal complaint ((b)(4)) was received indicating a grounding pad (part number 88-000102, lot 171000302) was not functioning properly and shocked a physician during use.The initial complaint report indicated a sample was available for return.However, as of the date of this report, a sample has not been received.The fedex tag that was issued to the initial reporter has expired.When the complaint investigator contacted the customer to follow up on sample return, the investigator was told that sample may no longer be available.The grounding pad is manufactured by cathay manufacturing corp.And is purchased by deroyal through a distributor.A supplier corrective action request was sent to the distributor on july 5, 2018.As of the date of this report, a response has not been received.The investigation is ongoing at this time.When new and critical information is received, this report will be updated.
Event or Problem Description
The end user reported the grounding pad is not working properly.It caused the alarm on the unit to activate, which the end user speculates may be due to not making good contact.The doctor reportedly felt a shock.
Event or Problem Description
The end user reported the grounding pad is not working properly.It caused the alarm on the unit to activate, which the end user speculates may be due to not making good contact.The doctor reportedly felt a shock.
Additional Manufacturer Narrative
Root cause: in the supplier corrective action request, deroyal's distributor, one source trading, indicated no non-conformities were identified during the production or inspection process.Retention samples passed the manufacturer's internal inspection.Because the defective product was not returned, it could not be tested or analyzed.A root cause could not be identified.Corrective action: a corrective action has not been taken.Investigation summary: an internal complaint (b)(4) was received indicating a grounding pad (part number: 88-000102, lot: 171000302) was not functioning properly and shocked a physician during use.The initial complaint report indicated a sample was available for return.However, as of the date of this report, a sample has not been received.The fedex tag that was issued to the initial reporter has expired.When the complaint investigator contacted the customer to follow up on sample return, the investigator was told that sample may no longer be available.The grounding pad is manufactured by cathay manufacturing corp.And is purchased by deroyal through a distributor.A supplier corrective action request was sent to the distributor on july 5, 2018.As of the date of this report, a response has not been received.Deroyal sold (b)(4) cases of the finished good between december 16, 2016, to july 6, 2018.Each case contains (b)(4) each, which equates to (b)(4) sold.No similar complaints were identified.This results in a complaint-to-sales ratio of (b)(4).Deroyal will continue to monitor post market feedback and will recognize in the future if the issue recurs.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.

• Brand Name: GROUNDING PAD, ADULT
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CATHAY MANUFACTURING CORP.; no. 328, xishe road; maogang town, songjiang area; shanghai, shanghai 20160 7; CH 201607
• MDR Report Key: 7726719
• Report Number: 1060680-2018-00002
• Device Sequence Number: 904609
• Product Code: GEI
• UDI-Device Identifier: 00749756053297
• UDI-Public: 0749756053297
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K130027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2018

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: 88-000102
• Device Lot Number: 171000302
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/29/2018
• Supplement Date Received by Manufacturer: 06/29/2018
• Initial Report FDA Received Date: 07/27/2018
• Supplement Report FDA Received Date: 08/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1