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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GYRUS ACMI, INC EZDILATE BALLOON DILATOR (FW) 16-17-18

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GYRUS ACMI, INC EZDILATE BALLOON DILATOR (FW) 16-17-18 Back to Search Results
Model Number BD-400P-1880
Device Problem Insufficient Information (3190)
Patient Problem Perforation of Esophagus (2399)
Event Date 01/09/2019
Event Type  Injury  
Manufacturer Narrative

The device was not returned to olympus for evaluation. Insufficient information was provided by the user facility as multiple attempts were made to gather more detailed information regarding the reported event, however, no additional information was obtained. The cause of the reported event cannot be determined at this time. Olympus will continue to investigate this report to obtain more detailed information regarding the reported event. If additional information becomes available or if the device is returned at a later date, this report will be updated and supplemented accordingly.

 
Event Description

Olympus was informed that while using the device during an esophageal dilation procedure, the patient¿s esophagus was reportedly perforated. The patient required two clips be inserted into his esophagus to close the perforation. It is unknown if the intended procedure was completed.

 
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Brand NameEZDILATE BALLOON DILATOR (FW) 16-17-18
Type of DeviceEZDILATE BALLOON DILATOR
Manufacturer (Section D)
GYRUS ACMI, INC
136 turnpike road
southborough MA 01772
Manufacturer Contact
connie tubera
2400 ringwood avenue
san jose, CA 95131
4089355124
MDR Report Key8265992
MDR Text Key133703530
Report Number2951238-2019-00386
Device Sequence Number1
Product Code KNQ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,USER F
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/30/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/22/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberBD-400P-1880
Device LOT Number528038
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/04/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 01/22/2019 Patient Sequence Number: 1
Treatment
GIF-H190/ SN. UNK
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