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

Model Number	3252
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this time, msi is waiting for device to be returned so an investigation can be conducted.Once the device is back and the results of the investigation are available, a final adverse event report will be submitted.
Event or Problem Description
On (b)(6) 2024, during the preparation of the surgical intervention in the operation room of the final customer "(b)(6) hospital " of the material "renew lapclinch grasper tp disposable, reference 3252-01, of the batch 00171558" it is seen that once opened, one leg of the tip is broken.

• Brand Name: LAPCLINCH GRASPER TIP, 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: 21019136
• Report Number: 1223422-2024-00051
• Device Sequence Number: 17161444
• Product Code: GEI
• UDI-Device Identifier: 00811099010074
• UDI-Public: 00811099010074
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K981389
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/26/2024

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: 00171558
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 12/26/2024
• 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