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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAUSCH & LOMB, INC. STORZ SIMCO DOUBLE BARRELED 1/A UNIT 23G; HAND HELD SURGICAL INSTRUMENT
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BAUSCH & LOMB, INC. STORZ SIMCO DOUBLE BARRELED 1/A UNIT 23G; HAND HELD SURGICAL INSTRUMENT Back to Search Results
Catalog Number E4971
Device Problem Material Fragmentation (1261)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/08/2014
Event Type  malfunction  
Event Description
The user facility reported during surgery flakes from the instrument went into the patient's eye.The flakes were removed, there was no injury to the patient.
 
Manufacturer Narrative
The instrument was received and inspected visually under a microscope.The instrument was manufactured in 2005.Tarnish was found on the instrument.It cannot be determined if this caused the flakes in the patients eye.The customer is instructed to refer to the proper cleaning instructions for silver instruments on storzeye.Com.
 
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Brand Name
STORZ SIMCO DOUBLE BARRELED 1/A UNIT 23G
Type of Device
HAND HELD SURGICAL INSTRUMENT
Manufacturer (Section D)
BAUSCH & LOMB, INC.
rochester NY 14609
Manufacturer (Section G)
BAUSCH & LOMB, INC.
3365 tree ct. industrial blvd.
Manufacturer Contact
sharon spencer, dir. qa
50 technology
irvine, CA 92618
9493985698
MDR Report Key4223646
MDR Text Key5067798
Report Number1920664-2014-00143
Device Sequence Number1
Product Code HNR
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/09/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/05/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberE4971
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer07/18/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/09/2014
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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