MAUDE Adverse Event Report: MICROLINE SURGICAL, INC. 10MM RENEW DISPOSABLE TENACULUM; MANUAL DETACHABLE SURGICAL INSTRUMENTS

Model Number	3422
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is being returned to microline surgical for investigation.No additional information is available at this time.
Event or Problem Description
10mm tip separated during manipulation of the uterus, during a hysterectomy case.
Additional Manufacturer Narrative
Nine devices were returned and subjected to detailed visual inspection.No physical damage was observed on any of the returned tips.Based on the event description, the jaws of the device reportedly became damaged and broke during the procedure.However, the actual device used during the procedure was not returned; therefore, functional testing could not be performed on the reported device.Breakage and bending of device jaws are consistent with damage resulting from excessive force.To simulate in-field use, functional testing was performed on an additional returned tip to attempt to reproduce the reported failure.The device was attached to a known-good handpiece and actuated.The device functioned as intended, successfully grasping and manipulating material without any issues.Further evaluation was conducted to replicate the reported condition.Excessive force and twisting were intentionally applied to the jaws while grasping material.The results demonstrated that a significant amount of force was required to produce damage consistent with that described in the complaint.Although complete fracture was not achieved during testing, the induced deformation (bending) indicates that, under sufficient loading conditions, the jaws can deform and potentially fracture when excessive force is applied.This complaint is confirmed.The reported damage is consistent with excessive force applied during use.A definitive root cause could not be established based on the available evidence; however, a probable contributing factor is user-applied excessive force.All devices undergo 100% final inspection for defects and damage prior to release.Based on these controls, it is unlikely that the device left microline in this condition.Microline will continue to monitor for similar occurrences.
Event or Problem Description
10mm tip separated during manipulation of the uterus, during a hysterectomy case.

• Brand Name: 10MM RENEW DISPOSABLE TENACULUM
• Common Device Name: MANUAL DETACHABLE SURGICAL INSTRUMENTS
• 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
• MDR Report Key: 24544198
• Report Number: 1223422-2026-00003
• Device Sequence Number: 9377436
• Product Code: GEI
• UDI-Device Identifier: 00811099014362
• UDI-Public: 00811099014362
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2026

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: 3422
• Device Catalogue Number: 3422
• Device Lot Number: 00181219
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2026
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2025
• 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