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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROSURGICAL TECHNOLOGY, INC. 23G, HOFFMAN/AHMED HORIZONTAL SCISSORS STR.; OPHTHALMIC SCISSOR
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MICROSURGICAL TECHNOLOGY, INC. 23G, HOFFMAN/AHMED HORIZONTAL SCISSORS STR.; OPHTHALMIC SCISSOR Back to Search Results
Model Number DFH-0010
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/03/2014
Event Type  malfunction  
Event Description
The facility reported that the 23g, hoffman/ahmed horizontal scissor broke when the surgeon placed the scissor into the eye.The broken piece of the scissor was removed and the procedure was completed as planned.There was no impact to the pt.
 
Manufacturer Narrative
The scissor was returned dirty and corroded at the site of the break indicating it had not been maintained adequately per the instructions for use.
 
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Brand Name
23G, HOFFMAN/AHMED HORIZONTAL SCISSORS STR.
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 Key4009234
MDR Text Key4955088
Report Number3019924-2014-00022
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 User Facility
Reporter Occupation Not Applicable
Remedial Action Replace
Type of Report Initial
Report Date 07/07/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/09/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberDFH-0010
Device Catalogue NumberDFH-0010
Device Lot Number048349
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer06/20/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received05/28/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Age2 YR
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