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

Model Number	3291
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this time, microline surgical is awaiting the device back.Once the device is returned and an investigation is completed, a final adverse event form will be submitted with more information.
Event or Problem Description
Tip broke inside of patient.Patient was not harmed and the grasper was retrieved intact.No serious injury.
Event or Problem Description
The tip broke inside the patient.The patient was not harmed, and the grasper was retrieved intact.No serious injury was reported.
Additional Manufacturer Narrative
The device was returned, decontaminated, and visually inspected.Upon inspection and functional testing, the complaint of a damaged tip was confirmed.Visual evaluation indicates this failure may be due to excessive force applied to the jaws.If the device is used in such a way that the jaws are fully opened and then forcefully engaged with tissue or another object, the applied stress may exceed the design tolerance.This can result in the crimp pin becoming the failure point, ultimately leading to breakage due to shear stress.This type of defect is not common.Microline will continue to monitor for similar occurrences.It is important to note that all devices undergo 100% final inspection for defects and damage prior to release.Therefore, it is unlikely that the device left microline in this condition.The complaint is confirmed.A possible root cause is likely due to excessive mechanical force during use.

• Brand Name: RENEW MODIFIED RAPTOR GRASPER TIP, REUSABLE
• 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: 22194813
• Report Number: 1223422-2025-00017
• Device Sequence Number: 18576799
• Product Code: GEI
• UDI-Device Identifier: 00811099011729
• UDI-Public: 00811099011729
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2025

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: 3291
• Device Catalogue Number: 3291
• Device Lot Number: 00165828
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2025
• Supplement Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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