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 09/03/2020

Event Type  malfunction  

Manufacturer Narrative

The subject device was not returned for evaluation.The user stated that the device is not available for return.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 was not deflating properly and got stuck in the scope.The user cut the balloon to allow the balloon to deflate.The user was able to pull the balloon back through the scope.The intended procedure was completed.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 the customer response and updates.Please see updated sections: b3, b5, d4,g4, g7, h2, h6 and h10.

Event Description

The procedure was esophagogastroduodenoscopy (egd)with dilation and malfunction occurred at the end of the procedure.There was a delay of approximately10-15 minutes while patient was under monitored anesthesia care (mac).The procedure was completed.There was no patient injury or harm to the patient or egd scope.

Manufacturer Narrative

This supplemental report is being submitted to provide review of the device history records (dhr) and investigation conclusion.The device was not returned and there are no pictures of the device so no physical evaluation is able to be performed.The oem (original equipment manufacturer) performed a dhr review and no abnormalities in documentation were noted.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: 10701111
• MDR Text Key: 212521783
• Report Number: 3003790304-2020-00113
• 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: 507050A
• 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: 10/26/2020; 12/01/2020
• Supplement Dates FDA Received: 11/24/2020; 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1