MAUDE Adverse Event Report: GYRUS ACMI, INC. 5 FR SCISSOR; HYSTEROSCOPE (AND ACCESSORIES)

Model Number	GYS-5
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
The customer reported that the end of the graspers on his olympus 5 fr scissors was broken.Reportedly, 1 of the 2 blades was missing altogether.Additional details relating to the patient and the event have been requested, but no response has been received at this time.There was no patient harm or consequence reported as a result of this event.
Additional Manufacturer Narrative
This report is being submitted to capture additional event and device information provided by the initial reporter.Should further information be provided another supplemental report will be submitted.
Event or Problem Description
Additional information was received from the initial reporter confirming that this event actually occurred during device reprocessing.
Additional Manufacturer Narrative
Correction to d4 (udi) for information inadvertently left out of previous report new information added to the following fields: d8.This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.The device was not returned to olympus for inspection, and the customer's complaint was not confirmed.Based on the results of the investigation, a definitive root cause could not be determined.Olympus will continue to monitor the field performance for this device.

• Brand Name: 5 FR SCISSOR
• 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: 20009832
• Report Number: 3011050570-2024-00335
• Device Sequence Number: 4362896
• Product Code: HIH
• UDI-Device Identifier: 00821925002562
• UDI-Public: 00821925002562
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K890328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/24/2024

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: GYS-5
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2024
• Supplement Date Received by Manufacturer: 09/05/2024; 10/18/2024
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 09/11/2024; 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown