MAUDE Adverse Event Report: GYRUS ACMI, INC. INFLATION DEVICE (DISPOSABLE) FOR EBD

Model Number MAJ-1740-D

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/16/2023

Event Type  malfunction  

Manufacturer Narrative

The subject device was received and evaluated.The return device was visually inspected , found no abnormalities in the appearance.Functional test was performed.During testing there were no issues observed.Functional test showed the pressure gauge moved without any problems.Based on device evaluation findings the reported issue of "pressure gauge meter did not move at all" was not confirmed.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

User facility reported when the staff opened the sterilized pack and sent the expansion fluid for use, staff noticed that the pressure gauge meter did not move at all.The device was replaced.The intended diagnostic procedure was completed using a similar device.There was no patient injury, no harm was reported, no user injury reported due to the event.

Manufacturer Narrative

Correction: model number and udi this report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the root cause of the event was unable to be identified.The lack of gauge response during functional testing of the complaint device indicates a clogged or corroded gauge filter.The gauge filter of the device was severely corroded with a crystallized substance.The crystalized deposits are left behind by a liquid that was introduced into the device and allowed to evaporate.These deposits obstruct the gauge from functioning properly.This indicates the device was misused, or used multiple times.Olympus will continue to monitor field performance for this device.

• Brand Name: INFLATION DEVICE (DISPOSABLE) FOR EBD
• Type of Device: INFLATION DEVICE (DISPOSABLE)
• 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: 16376544
• MDR Text Key: 309590056
• Report Number: 3003790304-2023-00073
• Device Sequence Number: 1
• Product Code: MAV
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K032840
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/09/2024

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: MAJ-1740-D
• Device Catalogue Number: MAJ-1740
• Device Lot Number: 96318032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/18/2023
• Initial Date FDA Received: 02/14/2023
• Supplement Dates Manufacturer Received: 02/06/2024
• Supplement Dates FDA Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1