STORZ BENGER PROBE HOOK E4222

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-08-18 for STORZ BENGER PROBE HOOK E4222 manufactured by Bausch & Lomb Inc..

Event Text Entries

[15322227] During the tdp (tear duct probe) procedure, the physician had a crochet hook in the set break at the tip while it was inside the nose of the patient. The object was removed and followed up with x-ray. Xray clear: no retained instrument. This is the fourth event reported with this medical device at this facility within approximately 6 months. Staff/physicians do not know what is causing the events to occur. The manufacturer has been notified and product has been returned.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 4026966
• MDR Report Key: 4026966
• Date Received: 2014-08-18
• Date of Report: 2014-07-28
• Date of Event: 2014-07-01
• Report Date: 2014-07-28
• Date Reported to FDA: 2014-08-18
• Date Reported to Mfgr: 2014-08-21
• Date Added to Maude: 2014-08-21
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: STORZ BENGER PROBE HOOK
• Generic Name: PROBE, LACRYMAL
• Product Code: HNW
• Date Received: 2014-08-18
• Returned To Mfg: 2014-07-14
• Model Number: E4222
• Catalog Number: E4222
• Lot Number: *
• ID Number: *
• Device Availability: R
• Device Age: 1 DA
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BAUSCH & LOMB INC.
• Manufacturer Address: 1400 N. GOODMAN STREET ROCHESTER NY 14609 US 14609

Device Sequence Number: 2

• Brand Name: STORZ BENGER PROBE HOOK
• Generic Name: PROBE, LACRYMAL
• Product Code: HNW
• Date Received: 2014-08-18
• Model Number: E4222
• Catalog Number: E4222
• Lot Number: *
• ID Number: *
• Device Availability: R
• Device Age: 1 DAY
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: BAUSCH & LOMB INC.
• Manufacturer Address: 1400 N. GOODMAN STREET ROCHESTER NY 14609 US 14609

Patients

Patient Number	Treatment	Outcome	Date
1	0		2014-08-18