Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAUSCH + LOMB STORZ SIMCO DOUBLE BARREL CANNULA
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BAUSCH + LOMB STORZ SIMCO DOUBLE BARREL CANNULA Back to Search Results
Model Number E4971
Device Problems Break (1069); Particulates (1451)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/22/2016
Event Type  malfunction  
Manufacturer Narrative
Based on all information, no causal factors can be determined and no conclusion can be drawn.
 
Event Description
Coating of the simcoe tip came off during operation.The coating material had to be flushed out of the patients eye.Additional information: the nurse did not keep the tip which was flushed out from patient¿s eye.There is no effect on the patient.
 
Manufacturer Narrative
The instrument was visually inspected under a microscope.There is no evidence of material defect or manufacturing error.The instrument has some tarnish on the silver, there is no signs of flaking.Found nothing wrong with instrument.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
STORZ SIMCO DOUBLE BARREL CANNULA
Type of Device
SIMCO DOUBLE BARREL CANNULA
Manufacturer (Section D)
BAUSCH + LOMB
rochester NY 14609
Manufacturer (Section G)
BAUSCH + LOMB
499 sovereign court
manchester MO 63011
Manufacturer Contact
sharon spencer
50 technology drive west
irvine, CA 92618
949398-569
MDR Report Key6257796
MDR Text Key65032278
Report Number0001920664-2017-00011
Device Sequence Number1
Product Code HNR
Combination Product (y/n)N
Reporter Country CodeSN
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/22/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/17/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Model NumberE4971
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/17/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/14/2017
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
-
-