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

Model Number	RB
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2023
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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.
Additional 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)
• Common Device Name: 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
• Report Number: 3011050570-2023-00191
• Device Sequence Number: 17803967
• Product Code: HIH
• UDI-Device Identifier: 00821925036444
• UDI-Public: 00821925036444
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K890328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2024

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2023
• Supplement Date Received by Manufacturer: 03/14/2024
• Initial Report FDA Received Date: 11/17/2023
• Supplement Report FDA Received Date: 03/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown