MAUDE Adverse Event Report: GYRUS ACMI, INC. ELITE & USA COLD KNIVES, STRAIGHT BLADE (3/PKG); URETHROTOME

Model Number	K-SB
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during cystoscopy with direct vision internal urethrotomy (dviu) , the knife fell off in the patient while incising a urethral stricture.A procedure delay occurred, but the time frame was unknown.A ct scan was used to visualize the knife, and a follow up cystoscopy with dviu was performed to retrieve the knife successfully 8 days later.Interoperative fluoroscopy was utilized during the follow up case as well to aid in knife retrieval.The patient was admitted to the hospital after the first procedure, but the time frame was unknown.It was stated that the second procedure was completed successfully.
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's (lm) investigation.The device history record was unable to be reviewed for this device based on the information provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.The subject device was not returned to olympus for evaluation.However, a photo of the device was provided and reviewed.Although there was no damage noted, only the stem portion of the device was visible in the photo.Based on the results of the investigation, the reported complaint could not be confirmed.Therefore, the root cause of the event could not be determined.This supplemental report includes a correction to a3, e2, e3, g2, and h8 to provide information that was inadvertently not included in the initial medwatch.Olympus will continue to monitor field performance for this device.

• Brand Name: ELITE & USA COLD KNIVES, STRAIGHT BLADE (3/PKG)
• Common Device Name: URETHROTOME
• 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: 20351284
• Report Number: 3011050570-2024-00401
• Device Sequence Number: 15459939
• Product Code: EZO
• UDI-Device Identifier: 00821925002661
• UDI-Public: 00821925002661
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: K-SB
• Device Lot Number: KR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2024
• Supplement Date Received by Manufacturer: 10/22/2024
• Initial Report FDA Received Date: 10/02/2024
• Supplement Report FDA Received Date: 11/08/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male