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

Model Number	NONB15STF
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During the laparoscopic surgical procedure a piece of the 15mm trocar that was inside the patient broke off.

• Brand Name: VERSAONE
• Common Device Name: LAPAROSCOPE, GENERAL PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 12576024
• Report Number: 12576024
• Device Sequence Number: 3908352
• Product Code: GCJ
• UDI-Device Identifier: 10884521548091
• UDI-Public: (01)10884521548091
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 09/24/2021
• Report Date (Section F): 09/24/2021

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: NONB15STF
• Device Catalogue Number: NONB15STF
• Device Lot Number: J1FJJ78Y
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/05/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/05/2021
• Patient Sequence Number: 1
• Patient Weight: 133
• Date Report Sent to FDA: 09/24/2021