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

Model Number	3221
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this time, msi is waiting for the device involved in the adverse event to be sent 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
A part of the tip broke and fell down into patient body after going into trocars.

• Brand Name: RENEW FENESTRATED GRASPER TIP, REUSABLE
• 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: 20863664
• Report Number: 1223422-2024-00045
• Device Sequence Number: 21040734
• Product Code: GEI
• UDI-Device Identifier: 00811099011651
• UDI-Public: 00811099011651
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K974066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/06/2024

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: 3221
• Device Catalogue Number: 3221
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2024
• Initial Report FDA Received Date: 12/06/2024
• 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: Unknown