MAUDE Adverse Event Report: MICROLINE SURGICAL RENEW REUSABLE FENESTRATED GRASPER; MANUAL DETACHABLE SURGICAL INSTRUMENTS

Model Number	3221
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Microline surgical is awaiting return of the product so that an investigation may be performed.
Event or Problem Description
The tip of the laparoscopic grasper instrument broke during a normal procedure.A metal part of the instrument fractured, creating a risk that small metal fragments could have entered and remained in the patient's abdominal cavity.The broken tip was retrieved, and all pieces appeared to be accounted for.
Additional Manufacturer Narrative
The device was returned, decontaminated, and subjected to a visual inspection.Upon evaluation, the complaint was confirmed due to the presence of a broken jaw.The manufacturing date of this device is from 2022.According to the renew reusable laparoscopic instrument tip instructions for use, the device is validated for 25 sterilization cycles,.The device's age suggests it may have exceeded its intended lifespan, potentially compromising material strength, particularly in the jaw slot area.Further visual inspection suggests that the failure may also 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.The complaint is confirmed.The likely root cause of the jaw damage is a combination of the device's age, excessive force, potential overuse beyond validated reprocessing limits.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.
Event or Problem Description
The tip of the laparoscopic grasper instrument broke during a normal procedure.A metal part of the instrument fractured, creating a risk that small metal fragments could have entered and remained in the patient's abdominal cavity.The broken tip was retrieved, and all pieces appeared to be accounted for.

• Brand Name: RENEW REUSABLE FENESTRATED GRASPER
• Common Device Name: MANUAL DETACHABLE SURGICAL INSTRUMENTS
• Manufacturer (Section D): MICROLINE SURGICAL; 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
• MDR Report Key: 24499921
• Report Number: 1223422-2026-00002
• Device Sequence Number: 10115312
• Product Code: GEI
• UDI-Device Identifier: 00811099011651
• UDI-Public: 00811099011651
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2026

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
• Device Lot Number: 00164897
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/24/2026
• Supplement Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown