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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 06/29/2017
Event Type  Injury  
Manufacturer Narrative

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. 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 a esophageal dilation procedure, the customer¿s esophagus was reportedly perforated. The patient required intervention and a clip was placed on the patient¿s esophagus to treat the perforation.

 
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Brand NameEZDILATE BALLOON DILATOR (FW) 16-17-18
Type of DeviceBALLOON 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 Key7803839
MDR Text Key117830253
Report Number2951238-2018-00480
Device Sequence Number1
Product Code KNQ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberEXEMPT-KNQ
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
Report Date 09/28/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/21/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberBD-400P-1880
Device Catalogue NumberBD-400P-1880
Device LOT Number527127A
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/26/2018
Was Device Evaluated By Manufacturer? Yes
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: 08/21/2018 Patient Sequence Number: 1
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