MAUDE Adverse Event Report: MICROLINE SURGICAL INC. RENEW ELECTROCAUTERY PROBE, 34CM, REUSABLE; ELECTROSURGICAL CAUTERY PROBE

Model Number	6924
Medical Device Problem Code	Unintended Electrical Shock (4018)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is a late mdr report, due to late reporting of event information from our field office.The reported device will be investigated upon its return to microline surgical, inc., to submit a 30-day follow-up.
Event or Problem Description
During a surgical procedure, the clinician experienced an electrical pulse feedback through the renew electrocautery probe.There was no harm to the patient or user.
Additional Manufacturer Narrative
The device was returned, decontaminated and visually inspected.There were no signs of physical damage, wear and tear to the device.A new tip was attached to the device.The device was then tested for functionality and for insulation.The device passed both tests without a defect or malfunction.No other defects were noted.This complaint is unconfirmed.
Event or Problem Description
During a surgical procedure, the clinician experienced an electrical pulse feedback through the renew electrocautery probe.There was no harm to the patient or user.

• Brand Name: RENEW ELECTROCAUTERY PROBE, 34CM, REUSABLE
• Common Device Name: ELECTROSURGICAL CAUTERY PROBE
• Manufacturer (Section D): MICROLINE SURGICAL INC.; 50 dunham road; suite 1500; beverly MA 01915
• MDR Report Key: 8033123
• Report Number: 1223422-2018-00032
• Device Sequence Number: 11107489
• Product Code: GEI
• UDI-Device Identifier: 00811099010913
• UDI-Public: 00811099010913
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K981188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2018

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: 6924
• Device Catalogue Number: 6924
• Device Lot Number: 00130454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2018
• Supplement Date Received by Manufacturer: 09/04/2018
• Initial Report FDA Received Date: 11/02/2018
• Supplement Report FDA Received Date: 11/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1