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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GYRUS ACMI INC. CUTTING LOOP

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GYRUS ACMI INC. CUTTING LOOP Back to Search Results
Model Number MLE-24-012
Device Problem Break (1069)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 05/09/2014
Event Type  Injury  
Event Description
The user facility reported that during a hysteroscopy procedure a piece of the device broke off inside the pt.The pt cavity and tissue was searched.However, nothing was found.The procedure was completed using the same device no pt injury was reported.
 
Manufacturer Narrative
The device referenced in this report was not returned to olympus for eval.If add'l info is received at a later time this report will be supplemented.
 
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Brand Name
CUTTING LOOP
Type of Device
LOOP
Manufacturer (Section D)
GYRUS ACMI INC.
136 turnpike rd
southborough MA 01772 210
Manufacturer (Section G)
GYRUS ACMI INC.
136 turnpike rd
southborough MA 01772 210
Manufacturer Contact
noemi schamback
2400 ringwood ave.
san jose, CA 95131
4089355002
MDR Report Key3839287
MDR Text Key4613564
Report Number2951238-2014-00208
Device Sequence Number1
Product Code HIN
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
Type of Report Initial
Report Date 05/09/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMLE-24-012
Device Catalogue NumberMLE-24-012
Device Lot Number111153GB
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/09/2014
Initial Date FDA Received05/20/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/21/2009
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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