MAUDE Adverse Event Report: GYRUS ACMI, INC. UNIVERSAL STOPCOCK, LUER LOCK; LARYNGOSCOPE, RIGID

Model Number 75U

Device Problem Failure to Clean Adequately (4048)

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

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was observed during the device inspection that the universal stopcock had multiple pieces of foreign material on the white plastic of the handle assembly and inside the stopcock body.There were no reports of patient harm.

• Brand Name: UNIVERSAL STOPCOCK, LUER LOCK
• Type of Device: LARYNGOSCOPE, RIGID
• 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: 19160664
• MDR Text Key: 341590200
• Report Number: 3011050570-2024-00141
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 00821925007321
• UDI-Public: 00821925007321
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K883819
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/22/2024

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: Other
• Device Model Number: 75U
• Device Lot Number: BC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2024
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/16/2024
• Initial Date FDA Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1