MAUDE Adverse Event Report: MICROLINE SURGICAL INC. RENEW ELECTROCAUTERY PROBE, 34CM, REUSABLE; MANUAL DETACHABLE SURGICAL INSTRUMENTS

Model Number	6924
Medical Device Problem Code	Arcing (2583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The associated product was not returned.Therefore, microline was unable to perform an investigation of this issue.
Event or Problem Description
The cautery probe and l hook were being used on 90 and spray to coagulate a liver bleed when the instrument melted and arched from the side burning an unintended portion of the liver.

• Brand Name: RENEW ELECTROCAUTERY PROBE, 34CM, REUSABLE
• Common Device Name: MANUAL DETACHABLE SURGICAL INSTRUMENTS
• Manufacturer (Section D): MICROLINE SURGICAL INC.; 50 dunham road; suite 1500; beverly MA 01915
• MDR Report Key: 12300014
• Report Number: 1223422-2021-00003
• Device Sequence Number: 3970954
• Product Code: GEI
• UDI-Device Identifier: 00811099010913
• UDI-Public: 00811099010913
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K981188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/10/2021

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: UNKNOWN
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/13/2021
• Initial Report FDA Received Date: 08/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1