MAUDE Adverse Event Report: BOSS INSTRUMENTS, LTD. BOSS EAR CUP FORCEPS; FORCEPS, ENT

Model Number 90-2181

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/02/2015

Event Type  malfunction  

Event Description

During an operative procedure, a micropituitary being used by doctor broke.The metal piece that broke off was retrieved.The instrument was removed from the sterile field and given to materials coord.An x-ray was taken and read as negative for metal.Doctor aware of x-ray results.No harm to the patient.

• Brand Name: BOSS EAR CUP FORCEPS
• Type of Device: FORCEPS, ENT
• Manufacturer (Section D): BOSS INSTRUMENTS, LTD.; 104 sommerfield drive; gordonsville VA 22942
• MDR Report Key: 4722176
• MDR Text Key: 18896428
• Report Number: 4722176
• Device Sequence Number: 1
• Product Code: KAE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 03/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 90-2181
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/19/2015
• Event Location: Hospital
• Date Report to Manufacturer: 04/23/2015
• Patient Sequence Number: 1
• Patient Age: 26 YR
• Patient Weight: 68