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

Model Number	UNVCA5STF
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Performing laparoscopic hysterectomy with insufflation and pressure could not be maintained.Stryker reps were called for troubleshooting.Problem did not resolve.Insufflation tubing was replaced and problem with maintaining pressure persisted.The stryker reps swapped out insufflation unit.Trocar being used was the suspected issue.Trocar removed from the field.

• Brand Name: VERSAONE
• Common Device Name: LAPAROSCOPE, GENERAL PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 18928954
• Report Number: 18928954
• Device Sequence Number: 9364675
• Product Code: GCJ
• UDI-Device Identifier: 30884521215423
• UDI-Public: (01)30884521215423
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/27/2024
• Report Date (Section F): 02/27/2024

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
• Device Model Number: UNVCA5STF
• Device Lot Number: J3H3373Y
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/19/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/19/2024
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Weight: 99 KG
• Patient Race: White
• Date Report Sent to FDA: 02/27/2024