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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROSURGICAL TECHNOLOGY, INC. 23G HOFFMAN/AHMED HORIZONTAL SCISSOR CURVED; OPHTHALMIC SCISSOR
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MICROSURGICAL TECHNOLOGY, INC. 23G HOFFMAN/AHMED HORIZONTAL SCISSOR CURVED; OPHTHALMIC SCISSOR Back to Search Results
Model Number DFH-0008
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
The user facility reported that the 23g hoffman/ahmed horizontal scissors broke when the surgeon attempted to cut iris tissue.On about the third or fourth cut the blade broke off but stayed in the vitreous where it was easily removed.There was no impact to the patient and the procedure was completed as planned.
 
Manufacturer Narrative
The facility reported that the device was cleaned using surgistain, an acidic detergent that is known to cause the device to become brittle and fracture easily.The dfu instructs users to clean the devices in a neutral ph detergent.
 
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Brand Name
23G HOFFMAN/AHMED HORIZONTAL SCISSOR CURVED
Type of Device
OPHTHALMIC SCISSOR
Manufacturer (Section D)
MICROSURGICAL TECHNOLOGY, INC.
redmond WA
Manufacturer Contact
8415 154th ave., n.e.
redmond, WA 98052
4255560544
MDR Report Key3793494
MDR Text Key4388780
Report Number3019924-2014-00004
Device Sequence Number1
Product Code HNF
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 Facility
Reporter Occupation Nurse
Remedial Action Replace
Type of Report Initial
Report Date 01/16/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/16/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberDFH-0008
Device Catalogue NumberDFH-0008
Device Lot Number043410
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer12/30/2013
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/17/2013
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2011
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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