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

Model Number	3252
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this time, the device involved in the adverse event has been discarded, but the hospital where the event occured has provided microline surgical, inc.Details of the event.The hospital has also submitted pictures of the device (after the adverse event) in question to msi, so an investigation will be conducted based on the information and pictures provided.When the investigation is complete, a final adverse event form will be submitted to the fda.
Event or Problem Description
During a lap cholecystectomy one of the grasper tips broke while inside the patient, the tip was replaced, and they found the metal piece that broke off in the patient and removed it.Inspection of the tip to ensure that all pieces were accounted for.

• Brand Name: RENEW LAPCLINCH GRASPER 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: 20371113
• Report Number: 1223422-2024-00035
• Device Sequence Number: 11684784
• Product Code: GEI
• UDI-Device Identifier: 00811099010074
• UDI-Public: 00811099010074
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K981389
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/04/2024

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: 3252
• Device Catalogue Number: 3252
• Device Lot Number: 00173028
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2024
• Initial Report FDA Received Date: 10/04/2024
• 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