MAUDE Adverse Event Report: Integra MicroFrance S.A.S. NEEDLE HOLDER CEV538T5 CVD TUNGSTEN; Microfrance Instruments

Catalog Number	CEV538T5
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2026
Type of Reportable Event	Malfunction

• Brand Name: NEEDLE HOLDER CEV538T5 CVD TUNGSTEN
• Common Device Name: Microfrance Instruments
• Manufacturer (Section D): Integra MicroFrance S.A.S.; le pavillon; le pavillon; saint aubin le monial 03160 ; FR 03160
• Manufacturer (Section G): Integra MicroFrance S.A.S.; le pavillon; saint aubin le monial 03160 ; FR 03160
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; +1(609)936-2319
• MDR Report Key: 50721013
• Report Number: 3003249645-2026-00038
• Device Sequence Number: 18255401
• Product Code: GCJ
• UDI-Device Identifier: 10381780093886
• UDI-Public: 10381780093886
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K080257
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/10/2026

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 Catalogue Number: CEV538T5
• Device Lot Number: 5306669
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2026
• Initial Report FDA Received Date: 09/10/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown