MAUDE Adverse Event Report: GYRUS ACMI, INC. LITHOSTENT 7.0X28CM; STENT, URETERAL

Model Number 5637028

Device Problem Packaging Problem (3007)

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

Event Date 12/11/2023

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

The customer reported to olympus, the lithostent had a crushed package on transport.The sterility was compromised.The issue was found during receipt inspection.There was no patient or procedure involvement.

• Brand Name: LITHOSTENT 7.0X28CM
• Type of Device: STENT, URETERAL
• Manufacturer (Section D): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer (Section G): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18423320
• MDR Text Key: 331930601
• Report Number: 3011050570-2024-00003
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 00821925005129
• UDI-Public: 00821925005129
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K960148
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/01/2024

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: 5637028
• Device Lot Number: MQKZ990
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/17/2023
• Initial Date FDA Received: 01/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1