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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GYRUS ACMI, INC EZDILATE BALLOON DILATOR (FW) 18-19-20

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GYRUS ACMI, INC EZDILATE BALLOON DILATOR (FW) 18-19-20 Back to Search Results
Model Number BD-400P-2080
Device Problem Deflation Problem (1149)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/14/2020
Event Type  malfunction  
Manufacturer Narrative
The subject device was not returned for evaluation.The user facility discarded the device.The cause of the issue cannot be determined at this time.If additional information becomes available this report will be supplemented accordingly.
 
Event Description
It was reported that during a therapeutic procedure, the balloon failed to deflate, not deflating properly and was getting stuck inside the probe when the user attempted to remove the balloon.No further details provided regarding the event.There was no patient harm or impact reported due to the event.No user injury reported.
 
Manufacturer Narrative
This supplemental report is being submitted to provide customer response and updates.Please see updated sections: b3, b5,g4, g7, h2, h6 and h10.
 
Event Description
The event occurred at the end of esophagogastroduodenoscopy (egd) procedure with approximately 10 minute delay and patient was under anesthesia.Intended procedure was completed and there was no patient harm or injury related to this event.
 
Manufacturer Narrative
This supplemental report is being submitted to provide the trend analysis and investigation conclusion.The root cause of the reported issue was not identified.The device was not returned for inspection and there are no images of the device provided to perform a physical inspection.The lot number of this device was reported to be unknown, the device history record (dhr) review is not able to be performed.Olympus will continue to monitor the field performance of this device.
 
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Brand Name
EZDILATE BALLOON DILATOR (FW) 18-19-20
Type of Device
EZDILATE BALLOON DILATOR (FW) 18-19-20
Manufacturer (Section D)
GYRUS ACMI, INC
136 turnpike road
southborough MA 01772
MDR Report Key10700666
MDR Text Key241742681
Report Number3003790304-2020-00112
Device Sequence Number1
Product Code KNQ
Combination Product (y/n)N
PMA/PMN Number
EXEMPT-KNQ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup,Followup
Report Date 12/08/2020
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 NumberBD-400P-2080
Device Lot NumberUNKNOWN
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/23/2020
Initial Date FDA Received10/19/2020
Supplement Dates Manufacturer Received10/30/2020
12/01/2020
Supplement Dates FDA Received11/25/2020
12/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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