MAUDE Adverse Event Report: COVIDIEN VERSA ONE BLUNT TROCAR WITH THREADED ANCHOR; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Model Number BPT12STS

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/06/2020

Event Type  malfunction  

Event Description

During surgery a 12mm trocar supply #bpt128sts lot # j9k0096dy broke when placing into patient's abdomen.A second trocar was received lot # j9kd0096dy trocar placed into abdomen without difficulty.Trocar broke in the same place the first one broke, all parts accounted for and placed in biohazard bag for review.The box of trocars pulled from shelf with corresponding lot #.Fda safety report id# (b)(4).

• Brand Name: VERSA ONE BLUNT TROCAR WITH THREADED ANCHOR
• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 9828860
• MDR Text Key: 183681281
• Report Number: MW5093713
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/11/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BPT12STS
• Device Lot Number: J9K0096DY
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 72