MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, INC. FLEXIPATH; TROCAR, DISPOSABLE

Model Number FP015

Device Problem Component Missing (2306)

Patient Problem No Information (3190)

Event Date 08/17/2018

Event Type  No Answer Provided  

Event Description

When the trocar was removed a piece was missing from the device.The surgeon was able to retrieve the missing piece.

• Brand Name: FLEXIPATH
• Type of Device: TROCAR, DISPOSABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, INC.; 4545 creek rd.; cincinnati OH 45242
• MDR Report Key: 7955486
• MDR Text Key: 123371827
• Report Number: 7955486
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Device Operator: No Information
• Device Model Number: FP015
• Device Catalogue Number: FP015
• Device Lot Number: P92V5C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/04/2018
• Date Report to Manufacturer: 10/11/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 17155 DA