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

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.

Manufacturer Narrative

This supplemental report is being submitted to report additional information from original equipment manufacturer (oem).The dhr was reviewed for this finished device and the subassembly for this device.Both finished and subassembly noted no abnormalities in documentation or process.The oem is unable to determine the root cause of the complaint and unable to confirm the nonconformance.No additional corrective action is being taken by the oem at this time, however complaint rate for this specific nonconformance will be trended.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information received.Olympus received additional information from the user facility that states that there was a small rent from the tip of dilator oozing into the patient¿s esophagus.The user facility reported that it is believed that possibly, the air pressure gauge did not seem accurate for the amount of water and pressure being applied.The balloon was inflated less than 20 mm.No x-ray was performed on the patient.The procedure was delayed for an unspecified period of time.The intended procedure was completed.The patient was discharged same day.Additionally, the balloon was inspected and lubricated prior to being placed on the distal end of the scope.The device was discarded after the procedure as per the facility¿s protocol.

• Brand Name: EZDILATE BALLOON DILATOR (FW) 16-17-18
• Type of Device: EZDILATE BALLOON DILATOR
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 8265992
• MDR Text Key: 133703530
• Report Number: 2951238-2019-00386
• Device Sequence Number: 1
• Product Code: KNQ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 12/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BD-400P-1880
• Device Lot Number: 528038
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GIF-H190/ SN. UNK; GIF-H190/ SN. UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR