MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. ADJUSTABLE BIOPSY PORT SEAL Y-ADAPTER,5/PKG; URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number BPS-Y

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was returned, and an initial evaluation was conducted by olympus; however, investigation is ongoing.If additional information becomes available following device evaluation, a supplemental report will be filed.

Event Description

As reported, the packaging of the adjustable biopsy port seal y-adapter contained a hair.There was no patient involvement during this event.

Manufacturer Narrative

The device was returned; however, the investigation is ongoing.If additional information becomes available prior to the investigation conclusion, a supplemental report will be filed.

Event Description

Additional event information was received noting that the hair was inside the sealed packaging.According to the reporter, there was no damage to the package of the device.There were no other issues known with any other packaging or devices in the same lot number.The problem was noted during procedure preparation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.The following sections were updated: g3, g6, h2,h3, h6 and h10.The returned device was evaluated.The customer returned the device still packaged; the sterile barrier was not breached.A close examination of the device while still inside the package does confirm that there is a hair inside the package.The hair was located on the port side with the larger diameter.The oem (original equipment manufacturer) performed a dhr (device history record) review on the assembly and sub-assembly.This review from the oem noted that there were no non-conformance's during the manufacturing of this specific product.The oem provided information regarding preventive measures that are currently in place in the manufacturing process.Oem reported there is a 100% inspection on the packaged map in boxing.This inspection includes inspecting for human matter (e.G.Eyelash, hair, blood) and is not allowed.The oem informed the technical teams of the failure and will continue to monitor this issue.Olympus will continue to monitor complaints for this device.

• Brand Name: ADJUSTABLE BIOPSY PORT SEAL Y-ADAPTER,5/PKG
• Type of Device: URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 west merit parkway; south jordan UT 84095
• MDR Report Key: 11317586
• MDR Text Key: 242061033
• Report Number: 3003790304-2021-00030
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 00821925031494
• UDI-Public: 00821925031494
• Combination Product (y/n): N
• PMA/PMN Number: K012758
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: BPS-Y
• Device Lot Number: K1821136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1