MAUDE Adverse Event Report: COVIDIEN LP VERSAONE BLADELESS TROCAR WITH FIXATION CANNULA; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	NONB15STF
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Seals on versaone bladeless trocar with fixation cannula x 2 are leaking.

• Brand Name: VERSAONE BLADELESS TROCAR WITH FIXATION CANNULA
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 18300606
• Report Number: 18300606
• Device Sequence Number: 16938133
• Product Code: GCJ
• UDI-Device Identifier: 10884521548091
• UDI-Public: (01)10884521548091
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/30/2023
• Report Date (Section F): 08/30/2023

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: Other
• Device Model Number: NONB15STF
• Device Catalogue Number: NONB15STF
• Device Lot Number: J3E0280Y
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/11/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/11/2023
• 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
• Patient Sex: Female
• Patient Weight: 96 KG
• Patient Race: White
• Date Report Sent to FDA: 08/30/2023