MAUDE Adverse Event Report: MICROLINE SURGICAL RENEW HANDPIECE, 34CM, REUSABLE; MANUAL DETACHABLE SURGICAL INSTRUMENT

Model Number	3904
Medical Device Problem Code	Arcing (2583)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	01/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Handle created an electric arc injuring the patient during a vaginal operation.

• Brand Name: RENEW HANDPIECE, 34CM, REUSABLE
• Common Device Name: MANUAL DETACHABLE SURGICAL INSTRUMENT
• Manufacturer (Section D): MICROLINE SURGICAL; 50 dunham rd suite 1500; beverly MA 01915
• Manufacturer (Section G): MICROLINE SURGICAL; 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: 16461271
• Report Number: 1223422-2022-00016
• Device Sequence Number: 20461661
• Product Code: GEI
• UDI-Device Identifier: 00811099010548
• UDI-Public: 00811099010548
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K962119
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/01/2023

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: 3904
• Device Catalogue Number: 3904
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2023
• Initial Report FDA Received Date: 03/01/2023
• 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: Female