MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD COHEN ACORN CANNULA,2-1/8 CERV CONE,LG FOR 505-230; INSTRUMENTS - MIS

Catalog Number	505232
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
The following was reported via medwatch number (b)(4) that during a laparoscopic ovarian cystectomy, the cohen acorn cannula,2-1/8 cerv cone,lg for 505-230 (505232) was "found to be functional; however, proper engagement of the cone tip requires a 180-degree twist for secure placement.No one noticed cone missing from device upon removal from use.No injury to patient, cone passed spontaneously through vagina while urinating.The cone was not noticed to be missing in the or.Physician was made aware by the patient after discharge, who then ensured no harm occurred.Patient returned cone to physician¿s office during follow up appointment who inspected cone and determined it was intact.The cone was not returned to the hospital." no patient injury or delay reported.

• Brand Name: COHEN ACORN CANNULA,2-1/8 CERV CONE,LG FOR 505-230
• Common Device Name: INSTRUMENTS - MIS
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA 02048
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA 02048
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 25023781
• Report Number: 3014334038-2026-00032
• Device Sequence Number: 18402006
• Product Code: GCJ
• UDI-Device Identifier: 10381780158370
• UDI-Public: 10381780158370
• Combination Product (Y/N): N
• PMA/510(K) Number: K060233
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 505232
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2026
• Supplement Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 04/28/2026
• Supplement Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: COHEN INTRAUTERINE PROBE 505230.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 34 YR
• Patient Sex: Unknown