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

Model Number	3142
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this time, microline surgical, inc.Is awaiting the affected device back from the hospital so an investigation can be conducted.Once the investigation is complete and more information is available, a final report will be submitted.
Event or Problem Description
During a laparoscopic ovarian cystectomy, the device failed to open and close during a critical part of the procedure.The tip was removed and replaced.
Additional Manufacturer Narrative
Despite requests from microline surgical, the device was never returned.Since the associated product was not returned to msi for investigation within 30+ days, this complaint was closed per pmf-q2-001.
Event or Problem Description
During a laparoscopic ovarian cystectomy, the device failed to open and close during a critical part of the procedure.The tip was removed and replaced.

• Brand Name: RENEW ENDOCUT SCISSOR TIP, 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: 21653178
• Report Number: 1223422-2025-00008
• Device Sequence Number: 18484749
• Product Code: GEI
• UDI-Device Identifier: 00811099010005
• UDI-Public: 00811099010005
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2025

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: 3142
• Device Catalogue Number: 3142
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2025
• Supplement Date Received by Manufacturer: 03/12/2025
• Initial Report FDA Received Date: 03/20/2025
• Supplement Report FDA Received Date: 06/06/2025
• 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 Age: 34 YR
• Patient Sex: Female