MAUDE Adverse Event Report: MICROLINE SURGICAL INC MODIFIED RAPTOR GRASPER, DISPOSABLE; RIGID ENDOSCOPIC TISSUE MANIPULATION FORCEPS, SINGLE-USE

Model Number	3292
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will not be returned to microline surgical, inc., so no investigation could be conducted.Therefore, the cause of the event is unknown.
Event or Problem Description
During procedure for patient, while using laparoscopic instrument with microline grasper tip inside the patient's body, one of the piece of grasper tip came off.The piece was removed from the patient.The device will not be returned to msi.

• Brand Name: MODIFIED RAPTOR GRASPER, DISPOSABLE
• Common Device Name: RIGID ENDOSCOPIC TISSUE MANIPULATION FORCEPS, SINGLE-USE
• 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: 19449710
• Report Number: 1223422-2024-00020
• Device Sequence Number: 18277756
• Product Code: GEI
• UDI-Device Identifier: 00811099010104
• UDI-Public: 00811099010104
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/03/2024

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: 3292
• Device Catalogue Number: 3292
• Device Lot Number: 00171336
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2024
• Initial Report FDA Received Date: 06/03/2024
• 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