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

Model Number	3222
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The associated device has not yet been returned to microline.A full investigation will be conducted once the device is received.
Event or Problem Description
Damage occurred during procedure when grasping a robotic sponge (cigar) approx.4mm in thickness.Unable to determine if a micro piece of metal is lost in patient.
Additional Manufacturer Narrative
Despite requests made to the manufacturer, the specific device associated with the complaint was not returned to msi for investigation within 30+ days.
Event or Problem Description
Damage occurred during procedure when grasping a robotic sponge (cigar) approx.4mm in thickness.Unable to determine if a micro piece of metal is lost in patient.
Additional Manufacturer Narrative
Despite multiple requests made, the specific device associated with this complaint was not returned to msi for evaluation within 30 days.As a result, a confirmed defect calculation could not be completed.Although the device was not returned, a capa investigation (car-0161) remains ongoing to identify potential root causes.
Event or Problem Description
Damage occurred during procedure when grasping a robotic sponge (cigar) approx.4mm in thickness.Unable to determine if a micro piece of metal is lost in patient.

• Brand Name: RENEW FENESTRATED GRASPER TIP, DISPOSABLE
• 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, MA 01915 ; 9789229810
• MDR Report Key: 23137245
• Report Number: 1223422-2025-00030
• Device Sequence Number: 21055029
• Product Code: GEI
• UDI-Device Identifier: 00811099010067
• UDI-Public: 00811099010067
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/21/2025

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: 00178061
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 09/24/2025
• Supplement Report FDA Received Date: 10/21/2025; 10/21/2025
• 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 Sex: Unknown