MAUDE Adverse Event Report: CATHAY MANUFACTURING CORP. ADULT HYDROGEL GROUNDING PAD; ELECTROSURGICAL

Model Number	88-000102
Medical Device Problem Codes	Unintended Power Up (1162); Unable to Obtain Readings (1516); Failure to Reset (1532)
Health Effect - Clinical Codes	Unspecified Reproductive System or Breast Problem (4513); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Root cause yet to be determined.The investigation is incomplete at this time, a follow-up report will be submitted with additional information once received, this report will be updated.
Event or Problem Description
The grounding pads in the lot were not reading so a separate pad from a different lot number was used instead.
Additional Manufacturer Narrative
A scar was completed by the manufacturer including the evaluation of the returned device and testing of saved samples from the same lot.No quality problems were identified during testing and the reported issue could not be replicated.From (b)(6) 2019 to (b)(6) 2021, (b)(4).During that time, there was 1 other complaint with the same failure code or part number.The work order was checked and showed no discrepancies.No root cause could be determined as no problems were able to be identified during testing.No corrective actions will be taken at this time.Complaints for this issue will continue to be monitored.No further information is available at this time.A follow up report will be submitted if additional information is received.

• Brand Name: ADULT HYDROGEL GROUNDING PAD
• Common Device Name: ELECTROSURGICAL
• Manufacturer (Section D): CATHAY MANUFACTURING CORP.; no. 328, xishe road; maogang town, songjang area, shanghai 20160 7; CH 201607
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1703 hwy 33 south; new tazewell TN 37825
• Manufacturer Contact: krupa bhalodia ; 200 debusk lane; powell, TN 37849 ; 8653621013
• MDR Report Key: 12514419
• Report Number: 1060680-2021-00005
• Device Sequence Number: 17016106
• Product Code: GEI
• UDI-Device Identifier: 50749756053292
• UDI-Public: 50749756053292
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K130027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 88-000102
• Device Lot Number: 210314601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/01/2021
• Supplement Date Received by Manufacturer: 12/14/2021
• Initial Report FDA Received Date: 09/22/2021
• Supplement Report FDA Received Date: 01/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown