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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-26-012
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/31/2015
Event Type  malfunction  
Event Description
Olympus was informed that during an unspecified procedure, the loop misfired, broke off and fell into the patient.The physician retrieved the broken piece from the patient and the procedure was completed.No patient injury was reported.Olympus followed up with the user facility via telephone and by mail to obtain more detailed information about the reported event, but with no results.
 
Manufacturer Narrative
The device referenced in this report has not yet been returned to olympus for evaluation.The exact cause of the reported event could not be conclusively determined.If additional information is received at a later time, this report will be supplemented.
 
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Brand Name
CUTTING LOOP
Type of Device
CUTTING LOOP
Manufacturer (Section D)
GYRUS ACMI INC
136 turnpike rd
southborough MA 01772 210
Manufacturer Contact
noemi schambach
2400 ringwood ave.
san jose, CA 95131
4089355002
MDR Report Key4726916
MDR Text Key16075725
Report Number2951238-2015-00210
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 Health Professional,User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 03/31/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMLE-26-012
Device Catalogue NumberMLE-26-012
Device Lot Number764453FF
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/31/2015
Initial Date FDA Received04/22/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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