MAUDE Adverse Event Report: ETHICON ENDO-SURGERY BLUNT TIP TROCAR

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Date 01/28/2008

Event Type  Injury  

Event Description

Ethicon 1/12 mm blunt tip broke off while removing from the abdomen.

• Brand Name: BLUNT TIP TROCAR
• Type of Device: TROCAR
• Manufacturer (Section D): ETHICON ENDO-SURGERY; 4545 creek rd.; cincinnati, OH 45242
• MDR Report Key: 5488693
• MDR Text Key: 39949074
• Report Number: 5488693
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/03/2016,03/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/03/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 03/03/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/09/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 33 YR