MAUDE Adverse Event Report: GYRUS ACMI, INC. EZDILATE BALLOON DILATOR (FW) 11-12-13

Model Number	BD-400P-1380
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that while performing an esophageal dilatation procedure, his olympus ez-dilate balloon dilator experienced a removal issue.According to the initial reporter, after inflating the unit to 13mm, it was unable to be retracted from the forceps port of the endoscope.Reportedly, this caused the entire endoscope to be removed and the balloon tip was cut with pliers.As this occurred in the final expansion stage, the procedure was completed and there was no patient harm caused.
Additional Manufacturer Narrative
The device has not been returned for evaluation.If additional information becomes available prior to the conclusion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation, the device evaluation and correction to e1.H7: this event has been associated with z # tbd / olympus ref # fy24-osta-08.The suspect device has been returned to olympus for evaluation and found that the balloon had been cut from the rest of the device, the cut was more toward the distal end, the cut was not very clean, and could confirm that the customer cut the device with pliers.The balloon appeared to have some bunching, which would confirm the device being stuck inside the scope the sheath of the device was very malformed, this is likely due to the customer pulling on the device when it was stuck in the scope.As the balloon was cut off, the balloon was unable to be inflated and deflated to test to the user's claim.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The investigation concluded that this nonconformance observed in this complaint was categorized as a process defect.An exhaustive revision of the process was completed, founding that occlusion partial or total was generated in the proximal bonding station due to misalignment of the d-mandrel or mandrel during the preparation for bonding process.The operator had not enough visibility to ensure the correct position of the d-mandrel or mandrel, causing melting material smearing occluding partial or total the diameter of the extrude.Causing two events, the first was the diameter is completely occluded which would prevent the balloon from inflating.And the second event would be that the diameter was partially occluded which would cause it to take longer to inflate or deflate.Olympus will continue to monitor field performance for this device.

• Brand Name: EZDILATE BALLOON DILATOR (FW) 11-12-13
• Common Device Name: BALLOON DILATOR
• Manufacturer (Section D): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• Manufacturer (Section G): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17584737
• Report Number: 3003790304-2023-00327
• Device Sequence Number: 20053704
• Product Code: KNQ
• UDI-Device Identifier: 00821925033184
• UDI-Public: 00821925033184
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT-KNQ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2023

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
• Operator of Device: Health Professional
• Device Model Number: BD-400P-1380
• Device Lot Number: 369624
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2023
• Supplement Date Received by Manufacturer: 11/20/2023
• Initial Report FDA Received Date: 08/21/2023
• Supplement Report FDA Received Date: 12/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/24/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED SCOPE.
• Patient Sex: Unknown