MAUDE Adverse Event Report: GYRUS ACMI, INC. DPIG HC 7X26; STENT, URETERAL

Model Number 5607026

Device Problem Delivered as Unsterile Product (1421)

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

Event Type  malfunction  

Event Description

The customer reported that during receipt inspection of the double pigtail ureteral stent, ¿the outer packaging was bent, and the seal was broken¿.The sterility of the device has been compromised.No death or injury and no impact to patient or other has been reported.Two devices with the same issue were reported by the customer.This report is for device 2 of 2.The first device is being reported on medwatch patient identifier (b)(6).

Manufacturer Narrative

The investigation is still in progress; however, if additional information becomes available, this report will be supplemented accordingly.

Manufacturer Narrative

The initial medwatch incorrectly reported the site registration number.The site registration number is 3011050570.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device was not returned to olympus for inspection, and the customer's complaint was unable to be confirmed.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 was unable to be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: DPIG HC 7X26
• 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: 16896163
• MDR Text Key: 314898321
• Report Number: 3005975494-2023-00089
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 00821925004078
• UDI-Public: 00821925004078
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K960148
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/03/2023

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: 5607026
• Device Lot Number: MQNM050
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/11/2023
• Initial Date FDA Received: 05/09/2023
• Supplement Dates Manufacturer Received: 05/01/2023; 07/27/2023
• Supplement Dates FDA Received: 05/18/2023; 08/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2022
• 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