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

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.

• 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 Key: 10700666
• MDR Text Key: 241742681
• Report Number: 3003790304-2020-00112
• Device Sequence Number: 1
• Product Code: KNQ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT-KNQ
• Number of Events Reported: 1
• 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 Number: BD-400P-2080
• Device Lot Number: UNKNOWN
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/23/2020
• Initial Date FDA Received: 10/19/2020
• Supplement Dates Manufacturer Received: 10/30/2020; 12/01/2020
• Supplement Dates FDA Received: 11/25/2020; 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1