MAUDE Adverse Event Report: GYRUS ACMI, INC. INFLATION DEVICE (DISPOSABLE) FOR EBD; CATHETER/OVERTUBE BALLOON INFLATOR, SINGLE-USE

Model Number MAJ-1740

Device Problem Shipping Damage or Problem (1570)

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

Event Date 02/27/2023

Event Type  malfunction  

Manufacturer Narrative

Six inflation devices with same model maj-1740, and lot # 96379129 was returned for evaluation.This device return evaluation is for patient identifier : (b)(6), lot 96379129.The subject device was visually inspected as received condition.Inspection found the shipping carton crushed on one side, however no moisture stains or wet spots on the outside of the box were observed.The inside was completely dry.The device came with its original package.Visual inspection of the white outer box found blue stains on the surface and the box had been opened, slightly crushed on both ends.However, the device packaging (tray) inside the white box was not affected and observed to be in sealed condition.There was no indication of moisture invasion, and the device was intact.Based on the evaluation of this box, the package found no sterile barrier damage, however, unknown blue stains on the outer box was observed.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

Company representative reported an out of box failure.Issue reported was that the ¿items got wet".The issue found during receipt inspection.The reported event involved the same model with the same lot (6 devices) in total.This report is being submitted due to report of "items got wet" (damaged packaging - sterility compromised).There was no patient involvement on this reported event.No harm was reported, no user injury reported.This event includes six (6) reports to capture the six devices of the same lot and model reported with issue of "items got wet ".Report with patient identifier (b)(6), lot 96379129.Report with patient identifier : (b)(6), lot 96379129 report with patient identifier: (b)(6), lot 96379129.Report with patient identifier: (b)(6), lot 96379129.Report with patient identifier: ((b)(6), lot 96379129.Report with patient identifier : (b)(6), lot 96379129.This report is for patient identifier:(b)(6), lot 96379129.

Manufacturer Narrative

This report is being supplemented to provide additional information based on device return evaluation of the original equipment manufacturer (oem) and investigation.This supplemental report is for device 1 out of 6 devices returned - (lot 96379129) - oem evaluated six devices of the same lot number.Device was manufactured in october 2022.A review of the device history records (dhr) for each lot indicated that the devices were manufactured under normal operating procedures and all final assembly devices were sampled, inspected and accepted.A review of the device history record found the subject device was shipped in accordance with specifications.The oem performed an investigation on this complaint.The oem received all six inflator devices.The oem noted the damages on the boxes and examined all of the devices individually.A visual inspection was conducted.Inspection noted the devices were not returned in the original oem¿s shipping container and the box that the complaint devices were returned in exhibited damage.The unit cartons of the complaint devices also exhibited damage and irregular light blue discoloration.The blue discoloration on the unit carton boxes was not the same color blue as found on the unit carton labels, and appears to have resulted from surface transfer scuffing but is unknown where the discoloration originated.The pre-shipment photograph also signifies that the shipment left the oems facility in good condition without any damage noted.All six devices passed the tray seal inspection (the tray seal integrity of the devices was within specifications) and with no issues found per oem¿s procedures and there was no sterility compromised.The oem was unable to confirm the complaint for the reported phenomenon of "sterility compromised" as no sterility compromised was observed, however, as noted, damages on the boxes were observed.Olympus will continue to monitor complaints for this device.Supplemental report(s) will be submitted should any relevant new information is available and or received.

• Brand Name: INFLATION DEVICE (DISPOSABLE) FOR EBD
• Type of Device: CATHETER/OVERTUBE BALLOON INFLATOR, SINGLE-USE
• 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: 16625020
• MDR Text Key: 312348321
• Report Number: 3003790304-2023-00130
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 00856877002537
• UDI-Public: 00856877002537
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032840
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/23/2023

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
• Device Operator: Health Professional
• Device Model Number: MAJ-1740
• Device Catalogue Number: MAJ-1740
• Device Lot Number: 96379129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/27/2023
• Initial Date FDA Received: 03/27/2023
• Supplement Dates Manufacturer Received: 06/19/2023
• Supplement Dates FDA Received: 06/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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