MAUDE Adverse Event Report: COVIDIEN AUTO BUTAR STRUCTIONAL TROCAR 10 MM

Lot Number P7M0185X

Device Problem Crack (1135)

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

Event Date 03/23/2018

Event Type  malfunction  

Event Description

Auto butar would not go in valve, appeared to be cracked.

• Brand Name: AUTO BUTAR STRUCTIONAL TROCAR 10 MM
• Type of Device: TROCAR
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 7411581
• MDR Text Key: 105187048
• Report Number: MW5076396
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: P7M0185X
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 50 YR