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

Model Number	88-E0031
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: an internal complaint ((b)(4)) was received regarding an electrosurgical pencil (part 88-e0031, lot 17060604) on which the "cut" button was not working.A sample was initially reported to be available and was requested november 26, 2018.However, as of the date of this report, that sample has not been returned.The investigator reviewed the purchase order for possible discrepancies that may have contributed to the reported event.No such discrepancies were found.The pencil is supplied to deroyal by vr medical technology.The 2015-2017 supplier corrective action request (scar) and supplier notification letter (snl) logs were reviewed for similar complaints.Other complaints for this item were identified, and 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.When new and critical information is available, this report will be updated.
Event or Problem Description
The cut button on the electrosurgical pencil was not working.
Additional Manufacturer Narrative
Root cause: the pencil is supplied to deroyal by vr medical.Therefore, a supplier corrective action request (scar) was issued to vr medical.In its response, vr medical said the returned sample was tested and found to be functioning normally and within product specification.Corrective action: in its scar response, vr medical stated a corrective action has not been taken due to the root cause determination.Investigation summary an internal complaint (call 45758) was received regarding an electrosurgical pencil (part 88-e0031, lot 17060604) on which the "cut" button was not working.A sample was initially reported to be available and was requested november 26, 2018.The sample was returned and forwarded to the supplier for evaluation.The investigator reviewed the quality record for possible discrepancies that may have contributed to the reported event.No such discrepancies were found.The pencil is supplied to deroyal by vr medical technology.The 2015-2017 supplier corrective action request (scar) and supplier notification letter (snl) logs were reviewed for similar complaints.Other complaints for this item were identified, and a scar was issued to vr medical.A response was received and accepted january 15, 2019, by deroyal personnel.The investigation is complete at this time.If new and critical information is available, this report will be updated.
Event or Problem Description
The cut button on the electrosurgical pencil was not working.

• 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, zhejiang 32105 1; CH 321051
• MDR Report Key: 8185269
• Report Number: 1060680-2018-00010
• Device Sequence Number: 19377797
• Product Code: GEI
• UDI-Device Identifier: 00749756803007
• UDI-Public: 00749756803007
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: K132199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2019

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: 17060604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2018
• Initial Date Received by Manufacturer: 11/23/2018
• Supplement Date Received by Manufacturer: 11/23/2018
• Initial Report FDA Received Date: 12/20/2018
• Supplement Report FDA Received Date: 02/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1