MAUDE Adverse Event Report: COVIDIEN LP VERSAONE; LAPAROSCOPE, GENERAL PLASTIC SURGERY

Model Number	ONB15STF
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
When inserting catch bag into trocar, the catch bag broke the seal to the trocar.Plastic piece got stuck inside the trocar and did not enter abdominal cavity.

• Brand Name: VERSAONE
• Common Device Name: LAPAROSCOPE, GENERAL PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN LP; 60 middletown ave.; north haven CT 06473
• MDR Report Key: 24638193
• Report Number: 24638193
• Device Sequence Number: 13222214
• Product Code: GCJ
• UDI-Device Identifier: 10884521185975
• UDI-Public: (01)10884521185975
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/27/2026
• Report Date (Section F): 02/27/2026

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: ONB15STF
• Device Catalogue Number: ONB15STF
• Device Lot Number: 1576PNI075002
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/19/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/19/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 02/27/2026