MAUDE Adverse Event Report: BAUSCH & LOMB, INC. STORZ BENGER PROBE HOOK; HAND HELD SURGICAL INSTRUMENT

Catalog Number E4222

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/03/2014

Event Type  malfunction  

Event Description

The user facility reported while the doctor was performing a tear duct procedure the probe broke inside the patient's nose.There was no injury to the patient.

• Brand Name: STORZ BENGER PROBE HOOK
• Type of Device: HAND HELD SURGICAL INSTRUMENT
• Manufacturer (Section D): BAUSCH & LOMB, INC.; rochester NY 14609
• Manufacturer Contact: sharon spencer, dir. ; 50 technology; irvine, CA 92618 ; 9493985698
• MDR Report Key: 3744290
• MDR Text Key: 22001963
• Report Number: 1920664-2014-00009
• Device Sequence Number: 1
• Product Code: HNL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: E4222
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/22/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1