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 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.

Manufacturer Narrative

This supplemental report is being submitted to provide the additional information and the physical evaluation of the device.The catheter and the inflation device were returned to olympus for evaluation.The cause of the reported event cannot be confirmed as the balloon and inflation device worked correctly.A visually inspection found there were no leaks from the balloon or the catheter, and no kinks in the catheter.It appears that the device functioned correctly.Based on the investigation results, it is not likely the device caused or contributed to the adverse event as the reported balloon and the inflation device functioned as expected.Additionally, a dhr review was conducted for the concerned lot number and found no abnormalities in documentation or the production process.

• Brand Name: EZDILATE BALLOON DILATOR (FW) 16-17-18
• Type of Device: BALLOON DILATOR
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 7803839
• MDR Text Key: 117830253
• Report Number: 2951238-2018-00480
• 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
• Report Date: 09/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BD-400P-1880
• Device Catalogue Number: BD-400P-1880
• Device Lot Number: 527127A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/06/2018
• Initial Date FDA Received: 08/21/2018
• Supplement Dates Manufacturer Received: 09/26/2018
• Supplement Dates FDA Received: 09/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: INFLATION DEVICE: OLYMPUS MAJ-174, LOT# UNK
• Patient Outcome(s): Required Intervention