MAUDE Adverse Event Report: MICROLINE SURGICAL INC RENEW ENDOCUT SCISSORS, DISPOSABLE; MANUAL DETACHABLE SURGICAL INSTRUMENT

Model Number	3142
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this time, microline surgical is awaiting the device back from amco.Once recieved, an investigation will be conducted and a final adverse event report will be submitted with the information from the investigation.
Event or Problem Description
The nurse realized that the edge of the back hub was dented.It seems that this part was initially dented since the handpiece was intact and the edge of the dent part was smooth.We cannot deny the possibility of the impact on insulation properties.

• Brand Name: RENEW ENDOCUT SCISSORS, DISPOSABLE
• Common Device Name: MANUAL DETACHABLE SURGICAL INSTRUMENT
• 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: 19624683
• Report Number: 1223422-2024-00023
• Device Sequence Number: 6359536
• Product Code: GEI
• UDI-Device Identifier: 00811099010005
• UDI-Public: 00811099010005
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K213127
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/27/2024

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: 3142
• Device Catalogue Number: 3142
• Device Lot Number: 00169985
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown