MAUDE Adverse Event Report: MICROLINE SURGICAL INC RENEW ELECTROCAUTERY PROBE, 34 CM, REUSABLE; ENDOSCOPIC ELECTROSURGICAL HANDPIECE/ELECTRODE, MONOPOLAR, REUSABLE

Model Number	6924
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	05/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is being sent back to microline surgical, inc and an investigation will be conducted.A final report will be submitted once the investigation is complete.
Event or Problem Description
Burned a patient, re-installed l-hook and tip was fine.

• Brand Name: RENEW ELECTROCAUTERY PROBE, 34 CM, REUSABLE
• Common Device Name: ENDOSCOPIC ELECTROSURGICAL HANDPIECE/ELECTRODE, MONOPOLAR, REUSABLE
• Manufacturer (Section D): MICROLINE SURGICAL INC; 50 dunham rd suite 1500; beverly MA 01915
• Manufacturer (Section G): MICROLINE SURGICAL INC; 50 dunham rd suite 1500; beverly MA 01915
• Manufacturer Contact: scott marchand davis ; 50 dunham rd suite 1500; beverly, MA 01915 ; 9789229810
• MDR Report Key: 19353368
• Report Number: 1223422-2024-00015
• Device Sequence Number: 7724993
• Product Code: GEI
• UDI-Device Identifier: 00811099010913
• UDI-Public: 00811099010913
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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 Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/20/2024

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: 6924
• Device Catalogue Number: 6924
• Device Lot Number: 00169558
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/07/2024
• Initial Report FDA Received Date: 05/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown