MAUDE Adverse Event Report: ZHEJIANG JINHUA HUATONG MEDICAL ELECTROSURGICAL PENCIL; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	88-E0031
Medical Device Problem Codes	Circuit Failure (1089); Electrical /Electronic Property Problem (1198); Electrical Shorting (2926)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: an internal complaint ((b)(4)) was received indicating an electrosurgical pencil (88-e0031, lot 18052301) was "getting an electrical short" during use.A sample was returned for evaluation and forwarded to the manufacturer.The pencil is supplied to deroyal by vr medical technology.The 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 vr medical.As of the date of this report, a response has not been received.The investigation is ongoing at this time.This report will be updated when new and critical information is received.
Event or Problem Description
The pencil is getting an electric shortage when soaked with blood or saline.The cautery machine either shows error or continuously coagulating/cutting without using the buttons.The end user is concerned it may lead to electric shock or severe injury to the patient or staff.
Additional Manufacturer Narrative
Root cause: the pencil is supplied to deroyal by vr medical technology.Therefore, a supplier corrective action request was issued to vr medical.In its response, vr medical stated the returned samples were sent to the manufacturer for testing.All samples worked normally with no short circuit defect occurring.Therefore, the root cause is unknown.Corrective action: based on the root cause determination, a corrective action has not been taken.Investigation summary an internal complaint (call 46083) was received indicating an electrosurgical pencil (88-e0031, lot 18052301) was "getting an electrical short" during use.Unused samples of the same lot were returned for evaluation and forwarded to the manufacturer.The pencil is supplied to deroyal by vr medical technology.Quality documentation for the reported lot was reviewed for possible discrepancies that may have contributed to the reported event.No discrepancies were identified.The 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 vr medical.A response was received and accepted may 14, 2019 by deroyal personnel.From 2017 to 2019, 1,658 cases of the reported finished good have been sold.Three similar complaints were identified, which equates to a sales-to-complaint ratio of 0.001809 or 0.181%.Deroyal will continue to monitor post market feedback and will recognize in the future if this issue reoccurs.The investigation is complete at this time.If new and critical information is received, this report will be updated.
Event or Problem Description
The pencil is getting an electric shortage when soaked with blood or saline.The cautery machine either shows error or continuously coagulating/cutting without using the buttons.The end user is concerned it may lead to electric shock or severe injury to the patient or staff.

• Brand Name: ELECTROSURGICAL PENCIL
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ZHEJIANG JINHUA HUATONG MEDICAL; no. 23 meixi road; wucheng district; jinhua, 32105 1; CH 321051
• MDR Report Key: 8333438
• Report Number: 1060680-2019-00002
• Device Sequence Number: 1304138
• Product Code: GEI
• UDI-Device Identifier: 50749756803002
• UDI-Public: 50749756803002
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• PMA/510(K) Number: K132199
• 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): 06/07/2019

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-E0031
• Device Lot Number: 18052301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2019
• Initial Date Received by Manufacturer: 01/14/2019
• Supplement Date Received by Manufacturer: 01/14/2019
• Initial Report FDA Received Date: 02/12/2019
• Supplement Report FDA Received Date: 06/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1