MAUDE Adverse Event Report: MIRCOLINE SURGICAL RENEW FENESTRATED GRASPER TIP DISPOSABLE; MANUAL DETACHABLE SURGICAL INSTRUMENT

Model Number	3222
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this time, microline surgical, inc.Is awaiting the affected device back so an investigation can be conducted.Once the results of the investigation are available, a final adverse event report will be submitted.
Event or Problem Description
During the case, one side of the grasper tip snapped off inside the patient.The surgeon was able to safely retrieve the broken piece, and the patient was not harmed.
Event or Problem Description
During the case, one side of the grasper tip snapped off inside the patient.The surgeon was able to safely retrieve the broken piece, and the patient was not harmed.
Additional Manufacturer Narrative
The associated product was not returned to microline inc., within 30 days.This complaint will be closed per qp4.19e.No further investigation is required.

• Brand Name: RENEW FENESTRATED GRASPER TIP DISPOSABLE
• Common Device Name: MANUAL DETACHABLE SURGICAL INSTRUMENT
• Manufacturer (Section D): MIRCOLINE SURGICAL; 50 dunham rd suite 1500; beverly, ma 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, MA 01915 ; 9789229810
• MDR Report Key: 23198471
• Report Number: 1223422-2025-00031
• Device Sequence Number: 21117062
• Product Code: GEI
• UDI-Device Identifier: 00811099010067
• UDI-Public: 00811099010067
• Combination Product (Y/N): N
• 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): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2025

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: 3222
• Device Catalogue Number: 3222
• Device Lot Number: 00179780
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/02/2025
• Supplement Report FDA Received Date: 10/29/2025
• Was Device Evaluated by Manufacturer? (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 Age: 31 YR
• Patient Sex: Female