MAUDE Adverse Event Report: GYRUS ACMI, INC. ROLLER BAR (6/PK); HYSTEROSCOPE (AND ACCESSORIES)

Model Number RB

Device Problem Sparking (2595)

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

Event Date 10/24/2023

Event Type  malfunction  

Event Description

The customer reported to olympus that the roller bar (6/pk) had a spark/light and then smelled different.The event occurred during a procedure.There was no patient harm associated with the event.

Manufacturer Narrative

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.

Manufacturer Narrative

This supplemental report is to provide a correction to the initial medwatch report.Initially, this complaint was submitted as a reportable malfunction conservatively.However, upon further review, this is being corrected to a non-reportable event.The initial medwatch reported the subject device had a spark/light and then smelled different; however; per the legal manufacturer, this issue is not likely to cause or contribute to death or serious injury if the malfunction were to recur.

• Brand Name: ROLLER BAR (6/PK)
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• 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: 18161150
• MDR Text Key: 328417752
• Report Number: 3011050570-2023-00191
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 00821925036444
• UDI-Public: 00821925036444
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K890328
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RB
• Device Lot Number: KR282085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/14/2024
• 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