MAUDE Adverse Event Report: Katalyst Surgical, LLC 27ga DEX¿ Super Grip II Forceps; FORCEPS, OPHTHALMIC

Model Number	DVF4036-27
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported in a complaint that the tips fell off with the impact of opening the tips.
Additional Manufacturer Narrative
The product was returned for investigation and found to have biomaterial present on the instrument.Examination of the break angle indicated failure due to lateral force applied in the same direction to both tips.The exact timing of the event could not be determined, as it may have occurred at any point after manufacture.

• Brand Name: 27ga DEX¿ Super Grip II Forceps
• Common Device Name: FORCEPS, OPHTHALMIC
• Manufacturer (Section D): Katalyst Surgical, LLC; 722 goddard avenue; chesterfield MO 63005
• Manufacturer (Section G): Katalyst Surgical, LLC; 722 goddard avenue; chesterfield MO 63005
• Manufacturer Contact: meryl wilhelm ; 722 goddard avenue; chesterfield, MO 63005 ; +1(636)536-5950
• MDR Report Key: 50229734
• Report Number: 3007589150-2026-00017
• Device Sequence Number: 21396541
• Product Code: HNR
• UDI-Device Identifier: 10840096202608
• UDI-Public: 10840096202608
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 08/12/2026

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: DVF4036-27
• Device Catalogue Number: DVF4036-27
• Device Lot Number: M46139
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/07/2025
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 08/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown