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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROSURGICAL TECHNOLOGY INC OSHER MALYUGIN MANIPULATOR; OPHTHALMIC HOOK
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MICROSURGICAL TECHNOLOGY INC OSHER MALYUGIN MANIPULATOR; OPHTHALMIC HOOK Back to Search Results
Model Number MAL-0003
Device Problems Material Fragmentation (1261); Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The device evaluation showed that the manipulator experienced extreme forces that bent and racked the ball of the device prior to use.The damage most likely occured during maintenance.
 
Event Description
A piece of the osher/malyugin manipulator came off in the patient's eye.Piece was removed without issue and surgery was completed as planned.
 
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Brand Name
OSHER MALYUGIN MANIPULATOR
Type of Device
OPHTHALMIC HOOK
Manufacturer (Section D)
MICROSURGICAL TECHNOLOGY INC
8415 154th ave ne
redmond WA 98052
Manufacturer (Section G)
MICROSURGICAL TECHNOLOGY INC
8415 154th ave ne
redmond WA 98052
Manufacturer Contact
robert may
8415 154th ave ne
redmond, WA 98052
4255560544
MDR Report Key5195832
MDR Text Key30570128
Report Number3019924-2015-00033
Device Sequence Number1
Product Code HNQ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Nurse
Remedial Action Replace
Type of Report Initial
Report Date 10/30/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Model NumberMAL-0003
Device Catalogue NumberMAL-0003
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/13/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/02/2015
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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